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Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT02500797
Recruitment Status : Suspended (Scheduled Interim Monitoring)
First Posted : July 17, 2015
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE July 15, 2015
First Posted Date  ICMJE July 17, 2015
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE July 30, 2015
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
Confirmed response rate [ Time Frame: Up to 6.5 years ]
The confirmed response rate will be estimated as the number of patients having a best objective tumor status of complete response (CR) or partial response (PR) lasting at least 4 weeks, divided by the number of evaluable patients.
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
Confirmed response rate estimated as the number of patients having a best objective tumor status of complete response (CR) or partial response (PR) lasting at least 4 weeks, divided by the number of evaluable patients [ Time Frame: Up to 3.5 years ]
Change History Complete list of historical versions of study NCT02500797 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Adverse event (AE) rates [ Time Frame: Up to 4 weeks after completion of study treatment ]
    graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (version 5.0 beginning April 1, 2018). Categorical data analysis will be used to summarize adverse event rates in each treatment arm and as a maximum severity during treatment for each patients and AE classification.
  • Duration of response [ Time Frame: Time from first response to progression, assessed up to 3 years ]
    Evaluated using Kaplan-Meier methodology.
  • Clinical benefit rate [ Time Frame: Up to 3 years ]
    Evaluated by counting the number of patients with a response or stable disease (PR, CR, stable disease) and dividing by the total number of evaluable patients.
  • Progression-free survival (PFS) [ Time Frame: Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years ]
    Evaluated using Kaplan-Meier methodology.
  • Overall survival (OS) [ Time Frame: Time from randomization to death from any cause, assessed up to 3 years ]
    Evaluated using Kaplan-Meier methodology.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2015)
  • Adverse event (AE) rates graded using the NCI CTCAE v4.0 [ Time Frame: Up to 4 weeks after completion of study treatment ]
    Categorical data analysis will be used to summarize adverse event rates and as a maximum severity during treatment for each patients and AE classification.
  • Clinical benefit rate [ Time Frame: Up to 3 years ]
    Evaluated by counting the number of patients with a response or stable disease (PR, CR, stable disease) and dividing by the total number of evaluable patients. In addition, the confirmed response rate will also be evaluated in patients who received at least 1 full cycle of treatment.
  • Duration of response [ Time Frame: Time from first response to progression, assessed up to 3 years ]
    Evaluated using Kaplan-Meier methodology.
  • Overall survival [ Time Frame: Time from randomization to death from any cause, assessed up to 3 years ]
    Evaluated using Kaplan-Meier methodology.
  • Progression-free survival [ Time Frame: Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years ]
    Evaluated using Kaplan-Meier methodology.
Current Other Pre-specified Outcome Measures
 (submitted: March 2, 2018)
  • PD-L1 expression assessed using immunohistochemistry (IHC) [ Time Frame: Up to 3 years ]
    Categorical data analysis and logistic regression will be used to evaluate the associations between PD-L1 expression (by IHC) and clinical outcome (eg, response, clinical benefit, progression-free survival, and survival). Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.
  • Change in selected biomarkers measured in serial peripheral blood [ Time Frame: Baseline to up to 3 years ]
    Summary statistics will be used to for describing changes across time. The time course of biomarker outcomes will be investigated graphically, by summary plots or individual patient plots. If there is suggestion of meaningful trend, methods such as linear mixed models may be used to characterize the pattern of change over time. Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.
  • Selected biomarkers measured in tumor tissue [ Time Frame: Up to week 6 ]
    Categorical data analysis and logistic regression will be used to correlated biomarkers with and clinical outcome (eg, response, clinical benefit, time to progression, progression free survival, and survival) within each study component. Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.
  • Confirmed response in patients who crossover from single agent nivolumab to dual agent treatment following progression [ Time Frame: Up to 3 years ]
    Confirmed response will be evaluated in patients who crossover from single agent nivolumab to dual agent treatment following progression.
  • Duration of response in patients who crossover from single agent nivolumab to dual agent treatment following progression [ Time Frame: Time from first response to progression, assessed up to 3 years ]
    Evaluated using Kaplan-Meier methodology.
  • Progression-free survival (PFS) in patients who crossover from single agent nivolumab to dual agent treatment following progression [ Time Frame: Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years ]
    Evaluated using Kaplan-Meier methodology.
  • Overall survival (OS) in patients who crossover from single agent nivolumab to dual agent treatment following progression [ Time Frame: Time from randomization to death from any cause, assessed up to 3 years ]
    Evaluated using Kaplan-Meier methodology.
Original Other Pre-specified Outcome Measures
 (submitted: July 15, 2015)
  • Change in selected biomarkers measured in serial peripheral blood [ Time Frame: Baseline to up to 3 years ]
    Summary statistics will be used to for describing changes across time. The time course of biomarker outcomes will be investigated graphically, by summary plots or individual patient plots. If there is suggestion of meaningful trend, methods such as linear mixed models may be used to characterize the pattern of change over time. Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.
  • PD-L1 expression (by IHC) [ Time Frame: Up to 3 years ]
    Categorical data analysis and logistic regression will be used to evaluate the associations between PD-L1 expression (by IHC) and clinical outcome (eg, response, clinical benefit, progression-free survival, and survival). Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.
  • Selected biomarkers measured in tumor tissue [ Time Frame: Up to week 6 ]
    Categorical data analysis and logistic regression will be used to correlated biomarkers with and clinical outcome (eg, response, clinical benefit, time to progression, progression free survival, and survival) within each study component. Kaplan-Meier methodology and Cox proportional hazards models will be used to evaluate time to event endpoints.
 
Descriptive Information
Brief Title  ICMJE Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery
Official Title  ICMJE Randomized Phase II Study of Nivolumab With or Without Ipilimumab in Patients With Metastatic or Unresectable Sarcoma
Brief Summary This randomized phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with sarcoma that has spread from the primary site to other parts of the body or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with metastatic or unresectable sarcoma.
Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the confirmed response rate of single agent nivolumab and dual agent nivolumab plus ipilimumab in patients with locally advanced/unresectable or metastatic soft tissue sarcoma.

SECONDARY OBJECTIVES:

I. To evaluate adverse event rates (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) within each treatment arm.

II. To evaluate duration of response, clinical benefit rate, time to progression, progression-free survival, and overall survival within each treatment arm.

CORRELATIVE SCIENCE OBJECTIVES:

I. To potentially detect an early signal of confirmed response rate within a histologically defined patient cohort.

II. To assess the potential association between programmed cell death 1 ligand 1 (PD-L1) expression (by immunohistochemistry [IHC]) and clinical outcome, within each treatment.

III. To evaluate associations between selected biomarker measured in serial peripheral blood and with clinical efficacy, within each treatment.

IV. To evaluate the association between selected biomarker measured in tumor tissue with clinical efficacy, within each treatment.

V. To evaluate the association between baseline tumor mutational burden and neoantigen production with clinical efficacy within each treatment.

EXPLORATORY PHASE II OBJECTIVES (CROSSOVER TREATMENT):

I. To evaluate secondary endpoints within patients crossing over to dual agent nivolumab plus ipilimumab after experiencing progressive disease while receiving single agent nivolumab.

II. To evaluate correlative science objectives endpoints within patients crossing over to dual agent nivolumab plus ipilimumab after experiencing progressive disease while receiving single agent nivolumab.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to Arm II.

ARM II: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.

After completion of study treatment, patients are followed up at 4 weeks and then every 6 months for 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dedifferentiated Liposarcoma
  • Gastrointestinal Stromal Tumor
  • Metastatic Liposarcoma
  • Metastatic Undifferentiated Pleomorphic Sarcoma
  • Pleomorphic Liposarcoma
  • Stage III Bone Sarcoma AJCC v7
  • Stage III Soft Tissue Sarcoma AJCC v7
  • Stage IV Bone Sarcoma AJCC v7
  • Stage IV Soft Tissue Sarcoma AJCC v7
  • Stage IVA Bone Sarcoma AJCC v7
  • Stage IVB Bone Sarcoma AJCC v7
  • Unresectable Liposarcoma
Intervention  ICMJE
  • Biological: Ipilimumab
    Given IV
    Other Names:
    • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
    • BMS-734016
    • MDX-010
    • MDX-CTLA4
    • Yervoy
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Biological: Nivolumab
    Given IV
    Other Names:
    • BMS-936558
    • MDX-1106
    • NIVO
    • ONO-4538
    • Opdivo
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
Study Arms  ICMJE
  • Experimental: Arm I (nivolumab)
    Patients receive nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to Arm II.
    Interventions:
    • Other: Laboratory Biomarker Analysis
    • Biological: Nivolumab
    • Other: Quality-of-Life Assessment
  • Experimental: Arm II (nivolumab, ipilimumab)
    Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    Interventions:
    • Biological: Ipilimumab
    • Other: Laboratory Biomarker Analysis
    • Biological: Nivolumab
    • Other: Quality-of-Life Assessment
Publications * D'Angelo SP, Mahoney MR, Van Tine BA, Atkins J, Milhem MM, Jahagirdar BN, Antonescu CR, Horvath E, Tap WD, Schwartz GK, Streicher H. Nivolumab with or without ipilimumab treatment for metastatic sarcoma (Alliance A091401): two open-label, non-comparative, randomised, phase 2 trials. Lancet Oncol. 2018 Mar;19(3):416-426. doi: 10.1016/S1470-2045(18)30006-8. Epub 2018 Jan 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 28, 2018)
195
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2015)
84
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • PRE-REGISTRATION ELIGIBILITY CRITERIA:
  • Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H&E) and 20 unstained sarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility
  • REGISTRATION ELIGIBILITY CRITERIA:
  • Patients must have histologically confirmed bone or soft tissue sarcoma by central pathology review

    • Patients must have histologically confirmed liposarcoma (LPS) (only dedifferentiated and pleomorphic; well differentiated not eligible), undifferentiated pleomorphic sarcoma (UPS)/malignant fibrous histiocytoma (MFH), or gastrointestinal stromal tumor (GIST)
  • Measurable disease
  • Locally advanced/unresectable or metastatic disease
  • >= 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy
  • No prior therapy with ipilimumab or nivolumab, or any agent targeting programmed cell death 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
  • No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration; for GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment
  • Patients should have resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, version 4.0, grade 1 or less
  • No history of the following:

    • Active known or suspected autoimmune disease
    • Patients with human immunodeficiency virus (HIV) are eligible if the lymphocytes > 350 cluster of differentiation (CD)4+ cells and no detectable viral load
    • Symptomatic, untreated, or uncontrolled brain metastases present
    • Active autoimmune colitis
    • Autoimmune panhypopituitarism
    • Autoimmune adrenal insufficiency
    • Known active hepatitis B or C

      • Hepatitis B can be defined as:

        • Hepatitis B surface antigen (HBsAg) > 6 months
        • Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/ml (105 copies/ml), lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B
        • Persistent or intermittent elevation in alanine aminotransferase (ALT)/alanine aminotransferase (AST) levels
        • Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
      • Hepatitis C can be defined as:

        • Hepatitis C antibody (Ab) positive
        • Presence of hepatitis C virus (HCV) ribonucleic acid (RNA)
    • Known active pulmonary disease with hypoxia defined as:

      • Oxygen saturation < 85% on room air or
      • Oxygen saturation < 88% despite supplemental oxygen
  • No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration
  • Not pregnant and not nursing because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects; therefore for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance > 45 mL/min using the lean body mass formula only
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); also, if hyperbilirubinemia is clearly attributed to liver metastases total bilirubin =< 3 x ULN is permitted
  • AST/ALT =< 3 x upper limit of normal (ULN)
  • Thyroid stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH if free T4 is normal and patient is clinically euthyroid, patient is eligible
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Measurable disease
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Locally advanced/unresectable or metastatic disease
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patient MUST have had progressive disease (radiographic or clinical) while on arm 1 single agent nivolumab while registered to A091401
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients removed from any immunotherapy for reasons other than progressive disease, including arm 1 single agent nivolumab of A091401, are NOT eligible for re-registration
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients must have completed a minimum of 10 weeks of single agent nivolumab on arm 1 of A091401 to be eligible for re-registration
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients must have completed study drug on arm 1 of A091401 (i.e., last dose of nivolumab) =< 12 months of re-registration to crossover dual agent therapy
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): No treatment with immunotherapy =< 21 days before re-registration; no treatment with biologic therapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before re-registration; no treatment with nitrosourea or mitomycin =< 42 days before re-registration
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients should have resolution of any toxic effects of prior therapy (except fatigue and alopecia) to NCI CTCAE, version 4.0, grade 1 or less, including immune toxicity
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of re-registration
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Not pregnant and not nursing because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to re-registration is required
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): ECOG performance status 0 or 1
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): ANC >= 1,500/mm^3
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Platelet count >= 100,000/mm^3
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Creatinine =< 1.5 ULN OR calc. creatinine clearance > 45 mL/min (using lean body mass formula only)
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION):: Total bilirubin =< 1.5 x ULN in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); if hyperbilirubinemia is clearly attributed to liver metastases, total bilirubin =< 3 x ULN is permitted
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): AST/ALT =< 3 x ULN
  • RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): TSH WNL; supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02500797
Other Study ID Numbers  ICMJE NCI-2015-00260
NCI-2015-00260 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
A091401
A091401 ( Other Identifier: Alliance for Clinical Trials in Oncology )
A091401 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandra P D'Angelo Alliance for Clinical Trials in Oncology
PRS Account National Cancer Institute (NCI)
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP