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Trial record 1 of 1 for:    2016-000210-29
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Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

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: NCT02807844
Recruitment Status : Completed
First Posted : June 21, 2016
Results First Posted : August 11, 2021
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study of MCS110 with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Pancreatic Carcinoma Melanoma Endometrial Carcinoma Drug: MCS110 Drug: PDR001 Phase 1 Phase 2

Detailed Description:

Combined treatment with MCS110 and PDR001 was expected to result in Tumor-associated macrophages (TAM) depletion, enhanced T-cell activation and synergistic antitumor activity in the clinical setting.

This study was a Phase Ib/II, multi-center, open label study starting with a Phase Ib dose escalation part followed by a Phase II part. MCS110 and PDR001 were administered i.v. Q3W until the patient experienced unacceptable toxicity, progressive disease as per irRC and/or treatment was discontinued at the discretion of the investigator or the patient. Patients were not to discontinue treatment based on progressive disease per Response evaluation criteria in solid tumors (RECIST) v1.1. During the Phase Ib part of the study, cohorts of patients were treated with increasing doses of MCS110 and PDR001 every 3 weeks until a Recommended Phase 2 Dose (RP2D) was determined for this treatment combination.

To assure that the combination RP2D did not exceed the Maximum tolerated dose (MTD), the combination MCS110 and PDR001 dose escalation was guided by a Bayesian logistic regression model (BLRM) with overdose control (EWOC) principle based on dose limiting toxicity data in the context of available safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) information. Once the MTD and/or RP2D was declared, additional patients were enrolled in the Phase II part in order to assess the preliminary anti-tumor activity of MCS110 in combination with PDR001 in anti-PD1/PD-L1-naive triple negative breast cancer (TNBC), pancreatic (PC), endometrial carcinoma (EC) and anti PD1/PD-L1-resistance melanoma (ME).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
Actual Study Start Date : June 29, 2016
Actual Primary Completion Date : June 4, 2020
Actual Study Completion Date : June 4, 2020


Arm Intervention/treatment
Experimental: Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W
Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W
Drug: MCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Other Name: colony-stimulating factor-1 [CSF-1])

Drug: PDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Experimental: Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W
Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W
Drug: MCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Other Name: colony-stimulating factor-1 [CSF-1])

Drug: PDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Experimental: Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W
Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W
Drug: MCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Other Name: colony-stimulating factor-1 [CSF-1])

Drug: PDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Experimental: Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W
Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W
Drug: MCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Other Name: colony-stimulating factor-1 [CSF-1])

Drug: PDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Experimental: Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W
Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W
Drug: MCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Other Name: colony-stimulating factor-1 [CSF-1])

Drug: PDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Experimental: Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W
Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W
Drug: MCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Other Name: colony-stimulating factor-1 [CSF-1])

Drug: PDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Experimental: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC
Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)
Drug: MCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Other Name: colony-stimulating factor-1 [CSF-1])

Drug: PDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Experimental: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC
Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)
Drug: MCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Other Name: colony-stimulating factor-1 [CSF-1])

Drug: PDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Experimental: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC
Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)
Drug: MCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Other Name: colony-stimulating factor-1 [CSF-1])

Drug: PDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Experimental: Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME
Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)
Drug: MCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Other Name: colony-stimulating factor-1 [CSF-1])

Drug: PDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.




Primary Outcome Measures :
  1. Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety [ Time Frame: From start of treatment to a maximum timeframe of 116.4 weeks for phase Ib ]
    Phase Ib: To characterize the safety and tolerability of MCS110 in combination with PDR001 in patients with advanced solid malignancies and to identify a recommended dose combination for Phase II.

  2. Phase II : Overall Response Rate (ORR) - Per RECIST v1.1 [ Time Frame: 4 years ]
    Overall Response Rate (ORR) is defined as the proportion of patients with a best overall response assessed by CT scan or MRI of complete response (CR), disappearance of all measurable and non-measurable lesions or partial response (PR), at least a 30% decrease in the sum of diameter of all measurable lesions, taking as reference the baseline sum of diameters,. based on local Investigator assessment, as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)

  3. Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean [ Time Frame: 4 years ]
    Overall Response Rate (ORR) is defined as the proportion of patients with a best overall response assessed by CT scan or MRI of complete response (CR), disappearance of all measurable and non-measurable lesions or partial response (PR), at least a 30% decrease in the sum of diameter of all measurable lesions, taking as reference the baseline sum of diameters,. based on local Investigator assessment, as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) - mean (FAS)

  4. Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1 [ Time Frame: 4 years ]
    Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per investigator based on Response evaluation criteria in solid tumors (RECIST) v1.1

  5. Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean [ Time Frame: 4 years ]
    Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per investigator based on Response evaluation criteria in solid tumors (RECIST) v1.1

  6. Phase Ib: Planned Dose Intensity - MCS110 [ Time Frame: Measured up to a max of 112.4 weeks ]
    To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Planned dose intensity for MCS110 is cumulative planned dose (mg/kg)/ number of doses scheduled per protocol during treatment period (i.e., this is equivalent to planned dose level).

  7. Phase Ib: Relative Dose Intensity - MCS110 [ Time Frame: Measured up to a max of 112.4 weeks ]
    To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Relative dose intensity (%) is 100 × dose intensity (mg/kg/3wks)/planned dose intensity (mg/kg/3wks).

  8. Phase Ib: Planned Dose Intensity - PDR001 [ Time Frame: Measured up to a max of 112.4 weeks ]
    To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Planned dose intensity for PDR001 (mg/3wks) is planned cumulative dose (mg)/ number of doses scheduled per protocol during treatment period (i.e., this is equivalent to planned dose level).

  9. Phase Ib: Relative Dose Intensity - PDR001 [ Time Frame: Measured up to a max of 112.4 weeks ]
    To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Relative dose intensity (%) is 100 × dose intensity (mg/3wks)/planned dose intensity (mg/3wks).

  10. Phase Ib: Number of Participants With Dose Reductions [ Time Frame: Measured up to a max of 112.4 weeks ]
    To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.

  11. Phase Ib: Number of Dose Interruptions Per Participant [ Time Frame: Measured up to a max of 112.4 weeks ]
    To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.

  12. Phase Ib: Number of Subjects With at Least One Dose Interruption [ Time Frame: Measured up to a max of 112.4 weeks ]
    To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.

  13. Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment [ Time Frame: the first 2 cycles of study treatment; cycle = 21 days (i.e., at day 42) ]
    Phase Ib: Dose limiting toxicities occurring during the first 2 cycles by system organ class, preferred term and maximum grade for Phase Ib. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 was used for all grading.


Secondary Outcome Measures :
  1. Phase II : Overall Response Rate (ORR) - Per irRC [ Time Frame: 4 years ]
    Phase II: Overall Response Rate (Complete response (CR) or Partial response (PR)) (with confirmation) as per investigator based on immune related Response criteria (irRC) (FAS)

  2. Phase Ib: Overall Response Rate (ORR) [ Time Frame: 4 years ]
    Phase Ib: Overall Response Rate (Complete response (CR) or Partial response (PR)), per RECIST v1.1 and per immune related Response criteria (irRC)

  3. Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean [ Time Frame: 4 years ]
    Phase II: Overall Response Rate (Complete response (CR) or Partial response (PR)) (with confirmation) as per investigator based on immune related Response criteria (irRC)- mean (FAS)

  4. Phase 1b: Clinical Benefit Rate (CBR) [ Time Frame: 4 years ]
    Phase 1b: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per RECIST v1.1 and per immune related Response criteria (irRC)

  5. Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC [ Time Frame: 4 years ]
    Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per immune related Response criteria (irRC)

  6. Phase II: Bayesian Inference of Clinical Benefit Rate - Per irRC - Mean [ Time Frame: 4 years ]
    Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per investigator based on immune related Response criteria (irRC)- mean (FAS)

  7. Phase 1b and Phase II: Progression Free Survival Based on Investigator Assessment as Per RECIST v1.1 and Per Immune Related Response Criteria (irRC) - Using Kaplan-Meier Method - Median [ Time Frame: Up to year 4 ]
    Phase 1b and Phase II: Progression Free Survival. Progression is defined as a 20% increase in the sum of diameter of measurable lesions taking as reference the smallest sum of diameter recorded at or after baseline, or worsening of non-measurable lesions or the appearance of new lesions, using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or Per Immune Related Response Criteria (irRC). Unlike RECIST 1.1, PD per irRC requires confirmation at a new assessment after at least 4 weeks - using Kaplan-Meier method - Median.

  8. Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median [ Time Frame: Up to year 4 ]
    Phase 1b and Phase II: Overall Survival - using Kaplan-Meier method - Median

  9. Phase 1b and Phase II: Duration of Response (DOR) [ Time Frame: 4 years ]
    Phase 1b and Phase II: Duration of Response (DOR) per RECIST v1.1 and per immune related Response criteria (irRC)

  10. Phase 1b and Phase II: Disease Control Rate (DCR) [ Time Frame: 4 years ]
    Phase 1b and Phase II: Disease Control Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) > 4 month)) per RECIST v1.1 and per immune related Response criteria (irRC)

  11. Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety [ Time Frame: From start of treatment to a maximum timeframe of 92.4 weeks for phase II. ]
    Phase II: To further characterize the safety and tolerability of MCS110 given in combination with PDR001

  12. Phase Ib and Phase II: Immunogenicity MCS110 [ Time Frame: 4 years ]
    Phase Ib and Phase II: Presence of anti-MCS110 antibodies

  13. Phase Ib and Phase II: Immunogenicity PDR001 [ Time Frame: 4 years ]
    Phase Ib and Phase II: Presence of anti-PDR001 antibodies

  14. Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]

    Phase Ib and Phase II: PK Parameters - AUClast, which is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass × time

    × volume-1); and AUCinf, which is the AUC from time zero to infinity (mass × time × volume-1) - MCS110


  15. Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]

    Phase Ib and Phase II: Pharmacokinetics (PK) Parameters - AUClast, which is the AUC from time zero to the last measurable concentration sampling time (tlast) (mass × time

    × volume-1); and AUCinf, which is the AUC from time zero to infinity (mass × time × volume-1) and AUCinf - PDR001


  16. Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - Cmax, which is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1); and Clast - MCS110

  17. Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - Cmax, which is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass × volume-1); and Clast - PDR001

  18. Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - Tmax, which is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time) - MCS110

  19. Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - Tmax, which is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time) - PDR001

  20. Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - T1/2, which is the terminal half-life associated with the terminal slope of a semi logarithmic concentration time curve (time) - MCS110

  21. Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - T1/2, which is the terminal half-life associated with the terminal slope of a semi logarithmic concentration time curve (time) - PDR001

  22. Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - CL, which is the total body clearance of drug from the plasma (volume × time-1) - MCS110

  23. Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - CL, which is the total body clearance of drug from the plasma (volume × time-1) - PDR001

  24. Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - Vz, which is the apparent volume of distribution during terminal phase (volume) - MCS110

  25. Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz [ Time Frame: cycle 1 (day 21) and cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - Vz, which is the apparent volume of distribution during terminal phase (volume) - PDR001

  26. Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) [ Time Frame: cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - Accumulation ratio (AR), which is the AUClast (multiple Dose)/AUClast (single dose) (for cycle 4 only) - MCS110

  27. Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) [ Time Frame: cycle 4 (day 84) ]
    Phase Ib and Phase II: PK Parameters - Accumulation ratio (AR), which is the AUClast (multiple Dose)/AUClast (single dose) (for cycle 4 only) - PDR001

  28. Phase Ib and Phase II: All Collected Deaths [ Time Frame: For ontreatment deaths: up to maximum timeframe of 116.4 weeks for phase Ib and 92.4 weeks for phase II. For total deaths: up to 3.8 years ]
    On treatment deaths are reported from the start of treatment until end of study treatment plus 30 days, up to maximum duration of 116.4 weeks for phase Ib and 92.4 weeks for phase II. Deaths post treatment survival follow up are reported after the on-treatment period, up to a maximum timeframe of 46 months (3.8 years).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • Signed informed consent prior to any procedures
  • Phase Ib part: Adult patients with advanced melanoma, endometrial carcinoma, pancreatic or TNBC, with measurable or non-measurable disease who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
  • Phase II part: Adult patients with advanced solid tumors who have received standard therapy (no more than 3 prior lines of treatment) or are intolerant of standard therapy, have progressed following their last prior therapy, and fit into one of the following groups:

    • Group 1: TNBC who did not receive prior anti-PD-1/PD-L1 treatment
    • Group 2: Pancreatic adenocarcinoma who did not receive prior anti-PD-1/PD-L1 treatment
    • Group 3: Endometrial carcinoma who did not receive prior anti-PD-1/PD-L1 treatment
    • Group 4: Melanoma who progressed on prior anti-PD-1/PD-L1 treatment.

Main Exclusion Criteria:

  • Patients with the following:

    • Symptomatic central nervous system (CNS) metastases or those requiring local CNS-directed therapy.
    • Abnormal liver, renal, or blood lab values.
    • Impaired cardiac function or clinically significant cardiac disease.
    • Active autoimmune disease or documented autoimmune disease within 3 years of screening.
    • Active infection requiring antibiotic therapy.
    • Known HIV, active hepatitis B or C virus.
    • Concurrent malignant disease.
  • Patients who received systemic anticancer therapy, major surgery, or radiotherapy within 2 weeks of study treatment, or live vaccines within 4 weeks of study treatment.
  • Patients requiring chronic treatment with systemic steroid therapy or any immunosuppressive therapy.
  • Patients who used hematopoietic colony-stimulating growth factors within 2 weeks of study treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807844


Locations
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United States, Massachusetts
Dana Farber Cancer Center
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63123
United States, Tennessee
The West Clinic
Germantown, Tennessee, United States, 38138
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Belgium
Novartis Investigative Site
Wilrijk, Belgium, 2610
Finland
Novartis Investigative Site
HUS, Finland, FIN-00029
France
Novartis Investigative Site
Saint Herblain cedex, France, 44805
Germany
Novartis Investigative Site
Frankfurt, Germany, 60590
Novartis Investigative Site
Ulm, Germany, 89081
Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Italy
Novartis Investigative Site
Milano, MI, Italy, 20133
Novartis Investigative Site
Milano, MI, Italy, 20141
Japan
Novartis Investigative Site
Koto ku, Tokyo, Japan, 135 8550
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of, 03080
Novartis Investigative Site
Seoul, Korea, Republic of, 05505
Spain
Novartis Investigative Site
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigative Site
Madrid, Spain, 28009
Switzerland
Novartis Investigative Site
Chur, Switzerland, 7000
Novartis Investigative Site
Geneve 14, Switzerland, CH 1211
Novartis Investigative Site
Zuerich, Switzerland, 8091
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] July 23, 2019
Statistical Analysis Plan  [PDF] June 29, 2020

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02807844    
Other Study ID Numbers: CMCS110Z2102
2016-000210-29 ( EudraCT Number )
First Posted: June 21, 2016    Key Record Dates
Results First Posted: August 11, 2021
Last Update Posted: August 11, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

URL: https://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Triple negative breast cancer
Pancreatic carcinoma
Melanoma
Endometrial Carcinoma
Immuno oncology
Monoclonal antibody
PDR001
MCS110
Advanced malignancies
metasteses
advanced cancer
malignant
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Neoplasms
Triple Negative Breast Neoplasms
Endometrial Neoplasms
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Spartalizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents