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Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02771626
Recruitment Status : Terminated (lack of efficacy)
First Posted : May 13, 2016
Results First Posted : March 17, 2023
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Calithera Biosciences, Inc

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Clear Cell Renal Cell Carcinoma (ccRCC)
Melanoma
Non-small Cell Lung Cancer (NSCLC)
Interventions Drug: CB-839
Drug: Nivolumab
Enrollment 118
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Hide Arm/Group Description Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic clear cell renal cell carcinoma (ccRCC), melanoma, and non-small cell lung cancer (NSCLC). Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one tyrosine kinase inhibitor (TKI) but are treatment naïve to checkpoint modulators programmed death-1/programmed death ligand-1 (PD-1/PD-L1), cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway. Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks. Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy. Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy. Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the epidermal growth factor receptor (EGFR) oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
Period Title: Overall Study
Started 8 26 17 9 37 21
Completed [1] 0 0 0 0 0 0
Not Completed 8 26 17 9 37 21
Reason Not Completed
Adverse Event             1             5             3             0             1             1
Radiologic Disease Progression             6             13             10             7             28             15
Symptomatic Deterioration             0             4             2             0             5             2
Participant Request             0             1             0             2             0             1
Investigator Decision             0             1             0             0             1             0
Study Termination by Sponsor             0             2             1             0             1             0
Informed Consent Withdrawn             0             0             1             0             1             1
Other, Not Specified             1             0             0             0             0             1
[1]
Study was terminated early. Participants still on study at the time of the study termination (see Reason Not Completed=Study Termination by Sponsor, below) were transferred to individual patient treatment Investigational New Drug applications (INDs) per physician and participant request.
Arm/Group Title Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy Total
Hide Arm/Group Description Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC. Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway. Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks. Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy. Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy. Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 8 26 17 9 37 21 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 26 participants 17 participants 9 participants 37 participants 21 participants 118 participants
59.5  (13.51) 58.4  (10.75) 67.8  (9.85) 63.2  (7.90) 63.4  (11.82) 67.0  (11.55) 63.3  (11.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 26 participants 17 participants 9 participants 37 participants 21 participants 118 participants
Female
3
  37.5%
8
  30.8%
3
  17.6%
2
  22.2%
15
  40.5%
11
  52.4%
42
  35.6%
Male
5
  62.5%
18
  69.2%
14
  82.4%
7
  77.8%
22
  59.5%
10
  47.6%
76
  64.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 26 participants 17 participants 9 participants 37 participants 21 participants 118 participants
Hispanic or Latino
2
  25.0%
3
  11.5%
0
   0.0%
0
   0.0%
2
   5.4%
1
   4.8%
8
   6.8%
Not Hispanic or Latino
6
  75.0%
23
  88.5%
17
 100.0%
9
 100.0%
33
  89.2%
20
  95.2%
108
  91.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   5.4%
0
   0.0%
2
   1.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 26 participants 17 participants 9 participants 37 participants 21 participants 118 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   3.8%
0
   0.0%
0
   0.0%
1
   2.7%
0
   0.0%
2
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
  11.5%
1
   5.9%
0
   0.0%
0
   0.0%
4
  19.0%
8
   6.8%
White
8
 100.0%
19
  73.1%
16
  94.1%
9
 100.0%
34
  91.9%
15
  71.4%
101
  85.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
3
  11.5%
0
   0.0%
0
   0.0%
2
   5.4%
2
   9.5%
7
   5.9%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Dose Interruption, Reduction, or Study Drug Discontinuation (Excluding Grade 5 Disease Progression)
Hide Description An adverse event (AE) is any untoward, undesired, or unplanned event that does not need to be causally related to treatment. A serious adverse event (SAE) is an AE that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in a persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, or important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based on appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Relatedness to study medication was graded as either, probably, possibly, unlikely, or unrelated. Events were categorized according to the Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death.
Time Frame From the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Hide Arm/Group Description:
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
Overall Number of Participants Analyzed 8 26 17 9 37 21
Measure Type: Count of Participants
Unit of Measure: Participants
≥ 1 TEAE
8
 100.0%
26
 100.0%
17
 100.0%
9
 100.0%
36
  97.3%
21
 100.0%
≥ 1 TEAE ≥ grade 3
5
  62.5%
17
  65.4%
8
  47.1%
4
  44.4%
17
  45.9%
12
  57.1%
≥ 1 TEAE related to nivolumab
6
  75.0%
22
  84.6%
15
  88.2%
8
  88.9%
28
  75.7%
17
  81.0%
≥ 1 TEAE related to telaglenastat
4
  50.0%
24
  92.3%
15
  88.2%
9
 100.0%
28
  75.7%
17
  81.0%
≥ 1 TEAE ≥ grade 3 related to nivolumab
0
   0.0%
6
  23.1%
6
  35.3%
2
  22.2%
4
  10.8%
5
  23.8%
≥ 1 TEAE ≥ grade 3 related to telaglenastat
0
   0.0%
5
  19.2%
6
  35.3%
2
  22.2%
4
  10.8%
4
  19.0%
≥ 1 grade 5 TEAE related to nivolumab
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
≥ 1 grade 5 TEAE related to telaglenastat
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
≥ 1 TEAE leading to discontinuation (DC) of nivolumab
1
  12.5%
6
  23.1%
3
  17.6%
0
   0.0%
1
   2.7%
3
  14.3%
≥ 1 TEAE leading to DC of telaglenastat
0
   0.0%
5
  19.2%
3
  17.6%
0
   0.0%
2
   5.4%
3
  14.3%
≥ 1 TEAE leading to DC of nivolumab and telaglenastat
0
   0.0%
4
  15.4%
3
  17.6%
0
   0.0%
1
   2.7%
3
  14.3%
≥ 1 TEAE leading to DC of nivolumab or telaglenastat
1
  12.5%
6
  23.1%
3
  17.6%
0
   0.0%
2
   5.4%
3
  14.3%
≥ 1 TEAE requiring nivolumab dose interruption or reduction
4
  50.0%
15
  57.7%
10
  58.8%
6
  66.7%
9
  24.3%
5
  23.8%
≥ 1 TEAE requiring telaglenastat dose interruption or reduction
4
  50.0%
16
  61.5%
9
  52.9%
6
  66.7%
14
  37.8%
10
  47.6%
≥ 1 TEAE requiring nivolumab and telaglenastat dose interruption or reduction
3
  37.5%
15
  57.7%
9
  52.9%
4
  44.4%
8
  21.6%
5
  23.8%
≥ 1 TEAE requiring nivolumab or telaglenastat dose interruption or reduction
4
  50.0%
16
  61.5%
10
  58.8%
8
  88.9%
15
  40.5%
10
  47.6%
≥ 1 grade 5 TEAE
1
  12.5%
1
   3.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
≥ 1 serious TEAE
2
  25.0%
7
  26.9%
6
  35.3%
1
  11.1%
9
  24.3%
6
  28.6%
≥ 1 serious TEAE ≥ grade 3
1
  12.5%
6
  23.1%
5
  29.4%
1
  11.1%
8
  21.6%
4
  19.0%
≥ 1 serious TEAE related to nivolumab
0
   0.0%
4
  15.4%
1
   5.9%
1
  11.1%
3
   8.1%
2
   9.5%
≥ 1 serious TEAE related to telaglenastat
0
   0.0%
3
  11.5%
2
  11.8%
0
   0.0%
2
   5.4%
3
  14.3%
≥ 1 serious TEAE ≥ grade 3 related to nivolumab
0
   0.0%
3
  11.5%
1
   5.9%
1
  11.1%
3
   8.1%
2
   9.5%
≥ 1 serious TEAE ≥ grade 3 related to telaglenastat
0
   0.0%
2
   7.7%
2
  11.8%
0
   0.0%
2
   5.4%
3
  14.3%
2.Primary Outcome
Title Number of Participants With Clinically Significant Treatment-Emergent Values in Hematology, Serum Chemistry Panel, Vital Signs or Weight
Hide Description Hematology assessments included: hemoglobin; hematocrit, red blood cell count, white blood cell count with differential, and platelet count. Serum chemistry panel included: sodium, potassium, chloride, carbon dioxide, calcium, glucose, blood urea nitrogen, total protein, albumin, total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, creatinine, thyroid stimulating hormone. Vital sign assessments included systolic and diastolic blood pressures, pulse (heart) rate, respiratory rate, temperature, and body weight.
Time Frame From the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Hide Arm/Group Description:
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
Overall Number of Participants Analyzed 8 26 17 9 37 21
Measure Type: Count of Participants
Unit of Measure: Participants
Hematology Values
0
   0.0%
3
  11.5%
1
   5.9%
0
   0.0%
1
   2.7%
1
   4.8%
Clinical Laboratory Values
1
  12.5%
4
  15.4%
3
  17.6%
0
   0.0%
2
   5.4%
2
   9.5%
Vital Sign Values
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Weight
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Overall Response Rate (ORR) Per Investigator Assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Hide Description

ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR or PR was required to be sustained for 4 weeks when confirmation was reported.

  • CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame up to a maximum of 2.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Hide Arm/Group Description:
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
Overall Number of Participants Analyzed 8 26 17 9 37 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 36.9)
24.0
(9.4 to 45.1)
5.9
(0.1 to 28.7)
0
(0 to 33.6)
5.4
(0.7 to 18.2)
0.0
(0.0 to 17.6)
4.Primary Outcome
Title Duration of Response (DOR) Per Investigator Assessed RECIST v1.1
Hide Description

DOR is defined as the time between the first documentation of a PR or a CR to the first documentation of progressive disease (PD) or death, whichever occurred first. DOR was censored at the date of last radiographic disease if the patient was alive and progression free at the time of database lock, PD, or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol treatment prior to documentation of disease progression.

  • CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
  • PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time Frame up to a maximum of 2.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a response.
Arm/Group Title Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Hide Arm/Group Description:
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
Overall Number of Participants Analyzed 0 6 1 0 2 0
Median (95% Confidence Interval)
Unit of Measure: months
13.01 [1] 
(11.01 to NA)
3.71 [2] 
(NA to NA)
9.59
(4.53 to 14.65)
[1]
Upper limit of confidence interval not available due to insufficient events above the median.
[2]
Not applicable since 1 participant analyzed.
5.Secondary Outcome
Title Progression-Free Survival (PFS) Per RECIST v1.1
Hide Description

PFS was defined as time from the first dose date to the earlier of either PD per RECIST v1.1 or death from any cause. The duration of PFS was censored at the date of last radiographic disease if the patient was alive and progression-free at the time of analysis data cutoff, disease progression, or death occurred after missing data for 2 consecutive radiographic disease assessments, or patient received non-protocol treatment prior to documentation of disease progression.

- PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Time Frame up to a maximum of 2.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an event (PD per RECIST v1.1 or death from any cause).
Arm/Group Title Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Hide Arm/Group Description:
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
Overall Number of Participants Analyzed 8 18 14 7 32 17
Median (95% Confidence Interval)
Unit of Measure: months
3.42
(1.74 to 9.33)
3.72
(1.84 to 12.85)
3.71
(1.87 to 5.52)
1.87
(1.81 to 5.52)
2.07
(1.87 to 3.75)
2.20
(1.74 to 5.59)
6.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from the first dose date to death due to any cause. For participants alive at time of analysis, overall survival was censored at the time when the participant was last known to be alive.
Time Frame up to a maximum of 2.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Hide Arm/Group Description:
Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy.
Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
Overall Number of Participants Analyzed 8 26 17 9 37 21
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(8.25 to NA)
24.54 [2] 
(16.30 to NA)
22.57 [2] 
(14.62 to NA)
NA [1] 
(26.25 to NA)
10.91
(8.87 to 18.14)
8.61
(4.11 to 19.71)
[1]
Insufficient events to establish the median and upper confidence limit.
[2]
Upper limit of confidence interval not available due to insufficient events above the median.
Time Frame All Cause Mortality: up to a maximum of 2.8 years. Adverse Events: from the first dose of study drug up to 28 days post last dose. Median duration of telaglenastat treatment was 92 days and that for nivolumab treatment was 84 days.
Adverse Event Reporting Description Per protocol, serious adverse events exclude those of Grade 5 disease progression.
 
Arm/Group Title Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Hide Arm/Group Description Telaglenastat 600 mg in combination with standard dose nivolumab in participants with advanced/metastatic ccRCC, melanoma, and NSCLC. Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who have previously received at least one TKI but are treatment naïve to checkpoint modulators PD-1/PD-L1, CTLA-4, or any other agent that specifically targets a T-cell checkpoint or co-stimulation pathway. Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC who received nivolumab in most recent treatment line that had documented radiological disease progression OR are currently receiving nivolumab with stable disease for at least 24 weeks. Telaglenastat 800 mg/standard dose nivolumab combination in participants with advanced/metastatic ccRCC that had documented radiological disease progression while receiving an anti-PD-1/PD-L1 therapy in any prior line of therapy. Telaglenastat 800 mg/standard dose nivolumab combination in participants with unresectable or metastatic melanoma that had documented radiological disease progression while receiving an anti-PD-1 therapy in their most recent line of therapy. Telaglenastat 800 mg/standard dose nivolumab combination in participants with NSCLC that does not harbor an activating mutation in the EGFR oncogene and who received nivolumab in most recent treatment line and had documented radiological disease progression OR are currently receiving nivolumab with Stable Disease for at least 24 weeks.
All-Cause Mortality
Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/8 (37.50%)   15/26 (57.69%)   11/17 (64.71%)   3/9 (33.33%)   27/37 (72.97%)   16/21 (76.19%) 
Hide Serious Adverse Events
Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   8/26 (30.77%)   6/17 (35.29%)   1/9 (11.11%)   12/37 (32.43%)   7/21 (33.33%) 
Blood and lymphatic system disorders             
Haemolysis † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Cardiac disorders             
Acute myocardial infarction † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Atrial fibrillation † 1  0/8 (0.00%)  0/26 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Tachycardia † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Gastrointestinal disorders             
Colitis † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Nausea † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  1/21 (4.76%) 
Vomiting † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  1/21 (4.76%) 
General disorders             
Disease progression † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  1/21 (4.76%) 
Pyrexia † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Hepatobiliary disorders             
Cholecystitis † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Hepatitis † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  1/21 (4.76%) 
Immune system disorders             
Immune system disorder † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  1/9 (11.11%)  0/37 (0.00%)  0/21 (0.00%) 
Infections and infestations             
Pneumonia † 1  0/8 (0.00%)  2/26 (7.69%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  1/21 (4.76%) 
Meningitis aseptic † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Septic shock † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Urinary tract infection † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  1/21 (4.76%) 
Urosepsis † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Injury, poisoning and procedural complications             
Compression fracture † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  2/37 (5.41%)  1/21 (4.76%) 
Fall † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Foreign body † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Pelvic fracture † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Investigations             
Alanine aminotransferase increased † 1  0/8 (0.00%)  1/26 (3.85%)  1/17 (5.88%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Aspartate aminotransferase increased † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders             
Hyperglycaemia † 1  0/8 (0.00%)  0/26 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  2/37 (5.41%)  0/21 (0.00%) 
Diabetes mellitus † 1  0/8 (0.00%)  0/26 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders             
Myositis † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  1/21 (4.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Cancer pain † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Malignant neoplasm progression † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Tumour haemorrhage † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Nervous system disorders             
Syncope † 1  0/8 (0.00%)  0/26 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Spinal cord compression † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  1/21 (4.76%) 
Psychiatric disorders             
Delirium † 1  0/8 (0.00%)  0/26 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Renal and urinary disorders             
Acute kidney injury † 1  1/8 (12.50%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Reproductive system and breast disorders             
Oedema genital † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease † 1  0/8 (0.00%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  1/21 (4.76%) 
Hypoxia † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Pneumothorax † 1  0/8 (0.00%)  0/26 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Respiratory arrest † 1  1/8 (12.50%)  0/26 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
Vascular disorders             
Hypotension † 1  0/8 (0.00%)  1/26 (3.85%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  0/21 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telaglenastat 600 mg + Standard Dose Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Recently Treated With Nivolumab Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: Melanoma With Prior PD-1 Therapy Telaglenastat 800 mg + Standard Dose Nivolumab: NSCLC With Prior PD-1 Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   26/26 (100.00%)   15/17 (88.24%)   9/9 (100.00%)   36/37 (97.30%)   21/21 (100.00%) 
Blood and lymphatic system disorders             
Anaemia † 1  4/8 (50.00%)  4/26 (15.38%)  4/17 (23.53%)  2/9 (22.22%)  8/37 (21.62%)  1/21 (4.76%) 
Eye disorders             
Photophobia † 1  1/8 (12.50%)  12/26 (46.15%)  4/17 (23.53%)  3/9 (33.33%)  12/37 (32.43%)  6/21 (28.57%) 
Vision blurred † 1  1/8 (12.50%)  6/26 (23.08%)  1/17 (5.88%)  1/9 (11.11%)  3/37 (8.11%)  0/21 (0.00%) 
Visual impairment † 1  1/8 (12.50%)  2/26 (7.69%)  0/17 (0.00%)  2/9 (22.22%)  1/37 (2.70%)  2/21 (9.52%) 
Gastrointestinal disorders             
Nausea † 1  3/8 (37.50%)  7/26 (26.92%)  6/17 (35.29%)  5/9 (55.56%)  16/37 (43.24%)  9/21 (42.86%) 
Constipation † 1  1/8 (12.50%)  5/26 (19.23%)  5/17 (29.41%)  4/9 (44.44%)  6/37 (16.22%)  8/21 (38.10%) 
Diarrhoea † 1  1/8 (12.50%)  9/26 (34.62%)  3/17 (17.65%)  3/9 (33.33%)  6/37 (16.22%)  4/21 (19.05%) 
Vomiting † 1  2/8 (25.00%)  4/26 (15.38%)  3/17 (17.65%)  2/9 (22.22%)  6/37 (16.22%)  7/21 (33.33%) 
Abdominal pain † 1  2/8 (25.00%)  7/26 (26.92%)  1/17 (5.88%)  0/9 (0.00%)  8/37 (21.62%)  3/21 (14.29%) 
Dry mouth † 1  0/8 (0.00%)  1/26 (3.85%)  3/17 (17.65%)  3/9 (33.33%)  5/37 (13.51%)  1/21 (4.76%) 
Dyspepsia † 1  0/8 (0.00%)  3/26 (11.54%)  1/17 (5.88%)  1/9 (11.11%)  4/37 (10.81%)  0/21 (0.00%) 
Abdominal distension † 1  0/8 (0.00%)  1/26 (3.85%)  2/17 (11.76%)  0/9 (0.00%)  2/37 (5.41%)  1/21 (4.76%) 
Stomatitis † 1  0/8 (0.00%)  3/26 (11.54%)  1/17 (5.88%)  1/9 (11.11%)  1/37 (2.70%)  0/21 (0.00%) 
General disorders             
Fatigue † 1  2/8 (25.00%)  14/26 (53.85%)  8/17 (47.06%)  6/9 (66.67%)  12/37 (32.43%)  8/21 (38.10%) 
Oedema peripheral † 1  2/8 (25.00%)  6/26 (23.08%)  2/17 (11.76%)  0/9 (0.00%)  3/37 (8.11%)  2/21 (9.52%) 
Pain † 1  0/8 (0.00%)  7/26 (26.92%)  3/17 (17.65%)  0/9 (0.00%)  1/37 (2.70%)  1/21 (4.76%) 
Chills † 1  1/8 (12.50%)  2/26 (7.69%)  3/17 (17.65%)  1/9 (11.11%)  3/37 (8.11%)  0/21 (0.00%) 
Pyrexia † 1  0/8 (0.00%)  2/26 (7.69%)  2/17 (11.76%)  1/9 (11.11%)  3/37 (8.11%)  2/21 (9.52%) 
Arthralgia † 1  4/8 (50.00%)  7/26 (26.92%)  3/17 (17.65%)  1/9 (11.11%)  5/37 (13.51%)  2/21 (9.52%) 
Infections and infestations             
Urinary tract infection † 1  1/8 (12.50%)  1/26 (3.85%)  0/17 (0.00%)  1/9 (11.11%)  4/37 (10.81%)  4/21 (19.05%) 
Upper respiratory tract infection † 1  2/8 (25.00%)  4/26 (15.38%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  1/21 (4.76%) 
Injury, poisoning and procedural complications             
Fall † 1  1/8 (12.50%)  0/26 (0.00%)  2/17 (11.76%)  1/9 (11.11%)  1/37 (2.70%)  4/21 (19.05%) 
Investigations             
Aspartate aminotransferase increased † 1  1/8 (12.50%)  5/26 (19.23%)  4/17 (23.53%)  1/9 (11.11%)  11/37 (29.73%)  3/21 (14.29%) 
Alanine aminotransferase increased † 1  0/8 (0.00%)  8/26 (30.77%)  4/17 (23.53%)  2/9 (22.22%)  7/37 (18.92%)  2/21 (9.52%) 
Blood creatinine increased † 1  2/8 (25.00%)  5/26 (19.23%)  4/17 (23.53%)  1/9 (11.11%)  3/37 (8.11%)  1/21 (4.76%) 
Blood alkaline phosphatase increased † 1  1/8 (12.50%)  1/26 (3.85%)  3/17 (17.65%)  1/9 (11.11%)  3/37 (8.11%)  0/21 (0.00%) 
Blood bilirubin increased † 1  0/8 (0.00%)  3/26 (11.54%)  4/17 (23.53%)  0/9 (0.00%)  1/37 (2.70%)  0/21 (0.00%) 
Weight decreased † 1  1/8 (12.50%)  2/26 (7.69%)  1/17 (5.88%)  1/9 (11.11%)  1/37 (2.70%)  2/21 (9.52%) 
Metabolism and nutrition disorders             
Decreased appetite † 1  2/8 (25.00%)  6/26 (23.08%)  7/17 (41.18%)  3/9 (33.33%)  6/37 (16.22%)  4/21 (19.05%) 
Hyponatraemia † 1  2/8 (25.00%)  5/26 (19.23%)  4/17 (23.53%)  1/9 (11.11%)  6/37 (16.22%)  2/21 (9.52%) 
Hypomagnesaemia † 1  1/8 (12.50%)  3/26 (11.54%)  2/17 (11.76%)  2/9 (22.22%)  5/37 (13.51%)  1/21 (4.76%) 
Hyperglycaemia † 1  1/8 (12.50%)  1/26 (3.85%)  3/17 (17.65%)  0/9 (0.00%)  3/37 (8.11%)  1/21 (4.76%) 
Hypophosphataemia † 1  0/8 (0.00%)  2/26 (7.69%)  2/17 (11.76%)  0/9 (0.00%)  2/37 (5.41%)  2/21 (9.52%) 
Dehydration † 1  1/8 (12.50%)  0/26 (0.00%)  0/17 (0.00%)  1/9 (11.11%)  3/37 (8.11%)  2/21 (9.52%) 
Hyperkalaemia † 1  1/8 (12.50%)  3/26 (11.54%)  0/17 (0.00%)  2/9 (22.22%)  0/37 (0.00%)  1/21 (4.76%) 
Hypokalaemia † 1  0/8 (0.00%)  0/26 (0.00%)  2/17 (11.76%)  0/9 (0.00%)  4/37 (10.81%)  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders             
Back pain † 1  2/8 (25.00%)  5/26 (19.23%)  3/17 (17.65%)  1/9 (11.11%)  4/37 (10.81%)  4/21 (19.05%) 
Pain in extremity † 1  1/8 (12.50%)  3/26 (11.54%)  1/17 (5.88%)  2/9 (22.22%)  3/37 (8.11%)  3/21 (14.29%) 
Muscular weakness † 1  0/8 (0.00%)  3/26 (11.54%)  3/17 (17.65%)  1/9 (11.11%)  1/37 (2.70%)  1/21 (4.76%) 
Musculoskeletal pain † 1  0/8 (0.00%)  1/26 (3.85%)  1/17 (5.88%)  1/9 (11.11%)  2/37 (5.41%)  3/21 (14.29%) 
Musculoskeletal chest pain † 1  2/8 (25.00%)  2/26 (7.69%)  1/17 (5.88%)  0/9 (0.00%)  1/37 (2.70%)  1/21 (4.76%) 
Myalgia † 1  1/8 (12.50%)  2/26 (7.69%)  2/17 (11.76%)  0/9 (0.00%)  1/37 (2.70%)  1/21 (4.76%) 
Nervous system disorders             
Headache † 1  1/8 (12.50%)  5/26 (19.23%)  5/17 (29.41%)  2/9 (22.22%)  5/37 (13.51%)  3/21 (14.29%) 
Dizziness † 1  0/8 (0.00%)  4/26 (15.38%)  3/17 (17.65%)  2/9 (22.22%)  7/37 (18.92%)  1/21 (4.76%) 
Psychiatric disorders             
Insomnia † 1  0/8 (0.00%)  5/26 (19.23%)  2/17 (11.76%)  1/9 (11.11%)  4/37 (10.81%)  3/21 (14.29%) 
Renal and urinary disorders             
Proteinuria † 1  0/8 (0.00%)  1/26 (3.85%)  2/17 (11.76%)  0/9 (0.00%)  5/37 (13.51%)  0/21 (0.00%) 
Haematuria † 1  1/8 (12.50%)  2/26 (7.69%)  1/17 (5.88%)  0/9 (0.00%)  2/37 (5.41%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough † 1  4/8 (50.00%)  7/26 (26.92%)  5/17 (29.41%)  4/9 (44.44%)  4/37 (10.81%)  4/21 (19.05%) 
Dyspnoea † 1  2/8 (25.00%)  7/26 (26.92%)  1/17 (5.88%)  1/9 (11.11%)  3/37 (8.11%)  3/21 (14.29%) 
Rhinorrhoea † 1  0/8 (0.00%)  5/26 (19.23%)  2/17 (11.76%)  2/9 (22.22%)  0/37 (0.00%)  0/21 (0.00%) 
Oropharyngeal pain † 1  0/8 (0.00%)  5/26 (19.23%)  1/17 (5.88%)  1/9 (11.11%)  1/37 (2.70%)  0/21 (0.00%) 
Productive cough † 1  1/8 (12.50%)  4/26 (15.38%)  0/17 (0.00%)  0/9 (0.00%)  0/37 (0.00%)  2/21 (9.52%) 
Skin and subcutaneous tissue disorders             
Pruritus † 1  4/8 (50.00%)  8/26 (30.77%)  4/17 (23.53%)  4/9 (44.44%)  3/37 (8.11%)  6/21 (28.57%) 
Dry skin † 1  0/8 (0.00%)  4/26 (15.38%)  4/17 (23.53%)  3/9 (33.33%)  2/37 (5.41%)  5/21 (23.81%) 
Rash † 1  3/8 (37.50%)  3/26 (11.54%)  2/17 (11.76%)  2/9 (22.22%)  3/37 (8.11%)  4/21 (19.05%) 
Rash macular † 1  0/8 (0.00%)  3/26 (11.54%)  1/17 (5.88%)  2/9 (22.22%)  1/37 (2.70%)  1/21 (4.76%) 
Rash maculo-papular † 1  0/8 (0.00%)  2/26 (7.69%)  1/17 (5.88%)  0/9 (0.00%)  1/37 (2.70%)  2/21 (9.52%) 
Vascular disorders             
Hypotension † 1  0/8 (0.00%)  3/26 (11.54%)  1/17 (5.88%)  1/9 (11.11%)  0/37 (0.00%)  1/21 (4.76%) 
1
Term from vocabulary, MedDRA 19.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No publication by the PI before either a multi-site publication or 18 months after final multi-site study report. PI can only publish their own results and provide 45 days in advance notice. PI must delete any Calithera confidential information from the publication other than study results and give good faith consideration to other comments made by Calithera. The PI must delay the publication for up to 45 days if requested by Calithera and publicly acknowledge Calithera and Pfizer support.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Calithera Biosciences, Inc
Phone: 650-870-1000
EMail: clinicaltrials@calithera.com
Layout table for additonal information
Responsible Party: Calithera Biosciences, Inc
ClinicalTrials.gov Identifier: NCT02771626    
Other Study ID Numbers: CX-839-004
First Submitted: May 6, 2016
First Posted: May 13, 2016
Results First Submitted: January 23, 2023
Results First Posted: March 17, 2023
Last Update Posted: March 17, 2023