Triple Negative Breast Cancer, Pancreatic Carcinoma, Melanoma, Endometrial Carcinoma
Conditions
Keywords
Triple negative breast cancer, Pancreatic carcinoma, Melanoma, Endometrial Carcinoma, Immuno oncology, Monoclonal antibody, PDR001, MCS110, Advanced malignancies, metasteses, advanced cancer, malignant
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.
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).
Interventions
DRUGMCS110
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
DRUGPDR001
MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | 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. |
| Phase II : Overall Response Rate (ORR) - Per RECIST v1.1 | 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) |
| Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean | 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) |
| Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1 | 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 |
| Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean | 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 |
| Phase Ib: Planned Dose Intensity - MCS110 | 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). |
| Phase Ib: Relative Dose Intensity - MCS110 | 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). |
| Phase Ib: Planned Dose Intensity - PDR001 | 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). |
| Phase Ib: Relative Dose Intensity - PDR001 | 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). |
| Phase Ib: Number of Participants With Dose Reductions | 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. |
| Phase Ib: Number of Dose Interruptions Per Participant | 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. |
| Phase Ib: Number of Subjects With at Least One Dose Interruption | 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. |
| Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | 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 |
| Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | 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 |
| Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | 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 |
| Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | 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 |
| Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | 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 |
| Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | 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 |
| Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | 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 |
| Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 | 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 |
| Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | 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 |
| Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL | 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 |
| Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | 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 |
| Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz | 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 |
| Phase II : Overall Response Rate (ORR) - Per irRC | 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) |
| Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 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 |
| Phase Ib and Phase II: All Collected Deaths | 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). |
| Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 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 |
| Phase Ib: Overall Response Rate (ORR) | 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) |
| Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean | 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) |
| Phase 1b: Clinical Benefit Rate (CBR) | 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) |
| Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC | 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) |
| Phase II: Bayesian Inference of Clinical Benefit Rate - Per irRC - Mean | 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) |
| 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 | 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. |
| Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | Up to year 4 | Phase 1b and Phase II: Overall Survival - using Kaplan-Meier method - Median |
| Phase 1b and Phase II: Duration of Response (DOR) | 4 years | Phase 1b and Phase II: Duration of Response (DOR) per RECIST v1.1 and per immune related Response criteria (irRC) |
| Phase 1b and Phase II: Disease Control Rate (DCR) | 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) |
| Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | 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 |
| Phase Ib and Phase II: Immunogenicity MCS110 | 4 years | Phase Ib and Phase II: Presence of anti-MCS110 antibodies |
| Phase Ib and Phase II: Immunogenicity PDR001 | 4 years | Phase Ib and Phase II: Presence of anti-PDR001 antibodies |
Countries
Belgium, Finland, France, Germany, Hong Kong, Italy, Japan, South Korea, Spain, Switzerland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | 12 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | 12 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | 13 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | 6 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | 11 |
| 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) | 20 |
| 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) | 20 |
| 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) | 21 |
| 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) | 20 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 2 |
| Overall Study | Death | 0 | 0 | 2 | 4 | 1 | 2 | 1 | 2 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 2 |
| Overall Study | Progressive disease | 5 | 12 | 8 | 8 | 3 | 8 | 14 | 17 | 19 | 15 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 3 Participants | 1 Participants | 3 Participants | 3 Participants | 0 Participants | 9 Participants | 12 Participants | 8 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 8 Participants | 10 Participants | 5 Participants | 8 Participants | 3 Participants | 20 Participants | 11 Participants | 9 Participants | 12 Participants | 95 Participants |
| Age, Continuous | 56.9 years STANDARD_DEVIATION 11.13 | 59.3 years STANDARD_DEVIATION 9.94 | 55.4 years STANDARD_DEVIATION 10.03 | 57.3 years STANDARD_DEVIATION 14.02 | 58.6 years STANDARD_DEVIATION 11.13 | 64.3 years STANDARD_DEVIATION 14.72 | 50.0 years STANDARD_DEVIATION 8.29 | 61.5 years STANDARD_DEVIATION 11.33 | 62.8 years STANDARD_DEVIATION 10.13 | 60.7 years STANDARD_DEVIATION 13.15 | 58.5 years STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 5 Participants | 4 Participants | 4 Participants | 7 Participants | 26 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) White | 12 Participants | 10 Participants | 11 Participants | 5 Participants | 9 Participants | 5 Participants | 14 Participants | 14 Participants | 14 Participants | 12 Participants | 106 Participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 8 Participants | 4 Participants | 6 Participants | 4 Participants | 20 Participants | 8 Participants | 21 Participants | 9 Participants | 96 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 5 Participants | 2 Participants | 5 Participants | 2 Participants | 0 Participants | 12 Participants | 0 Participants | 11 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 1 / 12 | 4 / 12 | 4 / 13 | 1 / 6 | 4 / 11 | 1 / 20 | 3 / 20 | 0 / 21 | 2 / 20 |
| other Total, other adverse events | 6 / 6 | 12 / 12 | 12 / 12 | 13 / 13 | 6 / 6 | 11 / 11 | 20 / 20 | 20 / 20 | 21 / 21 | 20 / 20 |
| serious Total, serious adverse events | 3 / 6 | 4 / 12 | 4 / 12 | 7 / 13 | 2 / 6 | 5 / 11 | 8 / 20 | 14 / 20 | 8 / 21 | 7 / 20 |
Outcome results
Primary
Phase Ib: Number of Dose Interruptions Per Participant
To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.
Time frame: Measured up to a max of 112.4 weeks
Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: MCS110 | 1.3 Dose interruptions per participant | Standard Deviation 1.97 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: PDR001 | 1.3 Dose interruptions per participant | Standard Deviation 1.97 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: MCS110 | 0.3 Dose interruptions per participant | Standard Deviation 0.45 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: PDR001 | 0.3 Dose interruptions per participant | Standard Deviation 0.45 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: MCS110 | 0.3 Dose interruptions per participant | Standard Deviation 0.45 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: PDR001 | 0.3 Dose interruptions per participant | Standard Deviation 0.45 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: MCS110 | 0.0 Dose interruptions per participant | Standard Deviation 0 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: PDR001 | 0.0 Dose interruptions per participant | Standard Deviation 0 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: MCS110 | 0.3 Dose interruptions per participant | Standard Deviation 0.52 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: PDR001 | 0.3 Dose interruptions per participant | Standard Deviation 0.52 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: MCS110 | 0.1 Dose interruptions per participant | Standard Deviation 0.3 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Dose Interruptions Per Participant | Number of dose interruptions per subject - Study drug: PDR001 | 0.1 Dose interruptions per participant | Standard Deviation 0.3 |
Primary
Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment
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.
Time frame: the first 2 cycles of study treatment; cycle = 21 days (i.e., at day 42)
Population: Dose Determination Set (DDS). A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Investigations - all grades | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) of subjects with at least one event - all grades | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Blood creatine phosphokinase increased - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Investigations - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) of subjects with at least one event - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Blood creatine phosphokinase increased - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Investigations - all grades | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) of subjects with at least one event - all grades | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Blood creatine phosphokinase increased - all grades | 1 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Investigations - all grades | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) of subjects with at least one event - all grades | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Blood creatine phosphokinase increased - all grades | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Investigations - all grades | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) of subjects with at least one event - all grades | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Blood creatine phosphokinase increased - all grades | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) of subjects with at least one event - all grades | 1 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Blood creatine phosphokinase increased - all grades | 1 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment | n (%) Investigations - all grades | 1 Participants |
Primary
Phase Ib: Number of Participants With Dose Reductions
To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.
Time frame: Measured up to a max of 112.4 weeks
Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: MCS110 | 6 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: PDR001 | 6 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: MCS110 | 12 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: PDR001 | 12 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: MCS110 | 12 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: PDR001 | 12 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: PDR001 | 13 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: MCS110 | 13 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: MCS110 | 6 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: PDR001 | 6 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: MCS110 | 9 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Participants With Dose Reductions | n (%) of participants with no dose reduction- Study drug: PDR001 | 11 Participants |
Primary
Phase Ib: Number of Subjects With at Least One Dose Interruption
To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.
Time frame: Measured up to a max of 112.4 weeks
Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - MCS110 | 3 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - PDR001 | 3 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - MCS110 | 3 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - PDR001 | 3 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - MCS110 | 3 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - PDR001 | 3 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - MCS110 | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - PDR001 | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - MCS110 | 2 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - PDR001 | 2 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - MCS110 | 1 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Number of Subjects With at Least One Dose Interruption | Number of subjects with at least one dose interruption - by reason - Adverse Event - PDR001 | 1 Participants |
Primary
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety
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.
Time frame: From start of treatment to a maximum timeframe of 116.4 weeks for phase Ib
Population: Safety Analysis Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events (AEs) - all grades | 6 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - Treatment-related - all grades | 6 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs requiring additional therapy - all grades | 6 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to dose adjustment / interruption - all grades | 4 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - all grades | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Serious Adverse Events (SAEs) - all grades | 3 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - all grades | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - Treatment-related - all grades | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events (AEs) - all grades | 12 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - Treatment-related - all grades | 12 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Serious Adverse Events (SAEs) - all grades | 4 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs requiring additional therapy - all grades | 12 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to dose adjustment / interruption - all grades | 4 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to dose adjustment / interruption - all grades | 4 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Serious Adverse Events (SAEs) - all grades | 4 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events (AEs) - all grades | 12 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - Treatment-related - all grades | 11 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs requiring additional therapy - all grades | 10 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs requiring additional therapy - all grades | 12 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - all grades | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events (AEs) - all grades | 13 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - Treatment-related - all grades | 8 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to dose adjustment / interruption - all grades | 2 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Serious Adverse Events (SAEs) - all grades | 7 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - all grades | 2 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events (AEs) - all grades | 6 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - Treatment-related - all grades | 2 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - Treatment-related - all grades | 6 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Serious Adverse Events (SAEs) - all grades | 2 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - all grades | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - all grades | 2 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - Treatment-related - all grades | 2 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to dose adjustment / interruption - all grades | 2 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs requiring additional therapy - all grades | 4 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Serious Adverse Events (SAEs) - all grades | 5 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - Treatment-related - all grades | 8 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs requiring additional therapy - all grades | 10 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to dose adjustment / interruption - all grades | 6 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events (AEs) - all grades | 11 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - Treatment-related - all grades | 1 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - all grades | 1 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - all grades | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - Treatment-related - all grades | 1 Participants |
Primary
Phase Ib: Planned Dose Intensity - MCS110
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).
Time frame: Measured up to a max of 112.4 weeks
Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Planned Dose Intensity - MCS110 | 0.86 mg/kg/3wks | Standard Deviation 0.191 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Planned Dose Intensity - MCS110 | 2.74 mg/kg/3wks | Standard Deviation 0.386 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Planned Dose Intensity - MCS110 | 2.66 mg/kg/3wks | Standard Deviation 0.435 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Planned Dose Intensity - MCS110 | 4.85 mg/kg/3wks | Standard Deviation 0.286 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Planned Dose Intensity - MCS110 | 7.05 mg/kg/3wks | Standard Deviation 0.594 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Planned Dose Intensity - MCS110 | 9.47 mg/kg/3wks | Standard Deviation 1.093 |
Primary
Phase Ib: Planned Dose Intensity - PDR001
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).
Time frame: Measured up to a max of 112.4 weeks
Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Planned Dose Intensity - PDR001 | 86.09 mg/3wks | Standard Deviation 19.058 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Planned Dose Intensity - PDR001 | 91.18 mg/3wks | Standard Deviation 12.873 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Planned Dose Intensity - PDR001 | 265.83 mg/3wks | Standard Deviation 43.528 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Planned Dose Intensity - PDR001 | 293.59 mg/3wks | Standard Deviation 16.013 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Planned Dose Intensity - PDR001 | 282.12 mg/3wks | Standard Deviation 23.773 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Planned Dose Intensity - PDR001 | 289.04 mg/3wks | Standard Deviation 20.329 |
Primary
Phase Ib: Relative Dose Intensity - MCS110
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).
Time frame: Measured up to a max of 112.4 weeks
Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Relative Dose Intensity - MCS110 | 100 Percentage | Standard Deviation 100 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Relative Dose Intensity - MCS110 | 100 Percentage | Standard Deviation 100 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Relative Dose Intensity - MCS110 | 100 Percentage | Standard Deviation 100 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Relative Dose Intensity - MCS110 | 99.23 Percentage | Standard Deviation 2.774 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Relative Dose Intensity - MCS110 | 100 Percentage | Standard Deviation 100 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Relative Dose Intensity - MCS110 | 100 Percentage | Standard Deviation 100 |
Primary
Phase Ib: Relative Dose Intensity - PDR001
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).
Time frame: Measured up to a max of 112.4 weeks
Population: Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Relative Dose Intensity - PDR001 | 100.00 Percentage | Standard Deviation 100 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Relative Dose Intensity - PDR001 | 100.00 Percentage | Standard Deviation 100 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Relative Dose Intensity - PDR001 | 100.00 Percentage | Standard Deviation 100 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Relative Dose Intensity - PDR001 | 100.00 Percentage | Standard Deviation 100 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Relative Dose Intensity - PDR001 | 100.00 Percentage | Standard Deviation 100 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Relative Dose Intensity - PDR001 | 100.00 Percentage | Standard Deviation 100 |
Primary
Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean
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
Time frame: 4 years
Population: Full Analysis Set. Since objective responses are rare in advanced pancreatic cancer and that long lasting stable disease is considered beneficial to patients, clinical benefit rate (confirmed objective response or SD\>4 months) was used as the primary endpoint for antitumor activity in this study changed from objective response to for this patient population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean | NA Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean | 0.8 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean | NA Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean | NA Percentage of participants |
Primary
Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean
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)
Time frame: 4 years
Population: Full Analysis Set. Since objective responses are rare in advanced pancreatic cancer and that long lasting stable disease is considered beneficial to patients, clinical benefit rate (confirmed objective response or SD\>4 months) was used as the primary endpoint for antitumor activity in this study changed from objective response to for this patient population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean | 6.7 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean | NA Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean | 10.8 Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean | 0.8 Percentage of participants |
Primary
Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1
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
Time frame: 4 years
Population: Full Analysis Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1 | 20 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1 | 0 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1 | 9.5 Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1 | 10.0 Percentage of participants |
Primary
Phase II : Overall Response Rate (ORR) - Per RECIST v1.1
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)
Time frame: 4 years
Population: Full Analysis Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II : Overall Response Rate (ORR) - Per RECIST v1.1 | 5 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II : Overall Response Rate (ORR) - Per RECIST v1.1 | 0 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II : Overall Response Rate (ORR) - Per RECIST v1.1 | 9.5 Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II : Overall Response Rate (ORR) - Per RECIST v1.1 | 0 Percentage of participants |
Secondary
Phase 1b and Phase II: Disease Control Rate (DCR)
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)
Time frame: 4 years
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate - as per investigator based on RECIST v1.1 | 33.3 Percentage |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate as per investigator based on irRC | 50.0 Percentage |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate - as per investigator based on RECIST v1.1 | 8.3 Percentage |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate as per investigator based on irRC | 8.3 Percentage |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate - as per investigator based on RECIST v1.1 | 0 Percentage |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate as per investigator based on irRC | 0 Percentage |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate - as per investigator based on RECIST v1.1 | 15.4 Percentage |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate as per investigator based on irRC | 15.4 Percentage |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate as per investigator based on irRC | 33.3 Percentage |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate - as per investigator based on RECIST v1.1 | 16.7 Percentage |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate as per investigator based on irRC | 18.2 Percentage |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate - as per investigator based on RECIST v1.1 | 18.2 Percentage |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate as per investigator based on irRC | 20.0 Percentage |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate - as per investigator based on RECIST v1.1 | 20.0 Percentage |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate - as per investigator based on RECIST v1.1 | 0 Percentage |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate as per investigator based on irRC | 5.0 Percentage |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate - as per investigator based on RECIST v1.1 | 19.0 Percentage |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate as per investigator based on irRC | 19.0 Percentage |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate - as per investigator based on RECIST v1.1 | 35.0 Percentage |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase 1b and Phase II: Disease Control Rate (DCR) | Disease Control Rate as per investigator based on irRC | 45.0 Percentage |
Secondary
Phase 1b and Phase II: Duration of Response (DOR)
Phase 1b and Phase II: Duration of Response (DOR) per RECIST v1.1 and per immune related Response criteria (irRC)
Time frame: 4 years
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on RECIST v1.1 | 372.0 days |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on irRC | 372.0 days |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on RECIST v1.1 | NA days |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on irRC | NA days |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on RECIST v1.1 | NA days |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on irRC | NA days |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on RECIST v1.1 | NA days |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on irRC | NA days |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on irRC | NA days |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on RECIST v1.1 | NA days |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on irRC | 155.0 days |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on RECIST v1.1 | 155.0 days |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on irRC | 169 days |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on RECIST v1.1 | 169 days |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on RECIST v1.1 | NA days |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on irRC | NA days |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on RECIST v1.1 | 328.5 days |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on irRC | 328.5 days |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on RECIST v1.1 | NA days |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase 1b and Phase II: Duration of Response (DOR) | Duration of response(days) - based on irRC | NA days |
Secondary
Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median
Phase 1b and Phase II: Overall Survival - using Kaplan-Meier method - Median
Time frame: Up to year 4
Population: Full Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | 12.3 months |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | 9.6 months |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | 4.2 months |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | 2.8 months |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | 22.8 months |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | 5.7 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | 8.9 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | 2.6 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | 11.7 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median | 19.7 months |
Secondary
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
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.
Time frame: Up to year 4
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | 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 | Median PFS - per RECIST v1.1 | 1.5 months |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | 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 | Median PFS - per iiRC | 8.2 months |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | 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 | Median PFS - per RECIST v1.1 | 1.3 months |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | 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 | Median PFS - per iiRC | 2.2 months |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | 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 | Median PFS - per RECIST v1.1 | 1.3 months |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | 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 | Median PFS - per iiRC | 1.3 months |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | 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 | Median PFS - per RECIST v1.1 | 1.1 months |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | 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 | Median PFS - per iiRC | 1.0 months |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | 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 | Median PFS - per iiRC | 1.3 months |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | 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 | Median PFS - per RECIST v1.1 | 1.3 months |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | 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 | Median PFS - per iiRC | 1.2 months |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | 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 | Median PFS - per RECIST v1.1 | 1.2 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | 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 | Median PFS - per iiRC | 1.6 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | 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 | Median PFS - per RECIST v1.1 | 1.6 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | 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 | Median PFS - per RECIST v1.1 | 1.3 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | 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 | Median PFS - per iiRC | 1.3 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | 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 | Median PFS - per RECIST v1.1 | 1.3 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | 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 | Median PFS - per iiRC | 1.3 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | 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 | Median PFS - per RECIST v1.1 | 2.4 months |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | 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 | Median PFS - per iiRC | 3.7 months |
Secondary
Phase 1b: Clinical Benefit Rate (CBR)
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)
Time frame: 4 years
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on RECIST v1.1 | 33.3 Percentage of participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on irRC | 50.0 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on RECIST v1.1 | 8.3 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on irRC | 8.3 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on irRC | 0 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on RECIST v1.1 | 0 Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on RECIST v1.1 | 0 Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on irRC | 7.7 Percentage of participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on RECIST v1.1 | 0 Percentage of participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on irRC | 33.3 Percentage of participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on irRC | 18.2 Percentage of participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase 1b: Clinical Benefit Rate (CBR) | Clinical Benefit Rate - as per investigator based on RECIST v1.1 | 18.2 Percentage of participants |
Secondary
Phase Ib and Phase II: All Collected Deaths
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).
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
Population: Clinical Database Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: All Collected Deaths | Total Deaths | 6 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: All Collected Deaths | On-treatment Deaths | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: All Collected Deaths | Total Deaths | 12 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: All Collected Deaths | On-treatment Deaths | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: All Collected Deaths | Total Deaths | 10 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: All Collected Deaths | On-treatment Deaths | 4 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: All Collected Deaths | Total Deaths | 12 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: All Collected Deaths | On-treatment Deaths | 4 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: All Collected Deaths | On-treatment Deaths | 1 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: All Collected Deaths | Total Deaths | 4 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: All Collected Deaths | On-treatment Deaths | 4 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: All Collected Deaths | Total Deaths | 10 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: All Collected Deaths | On-treatment Deaths | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: All Collected Deaths | Total Deaths | 11 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: All Collected Deaths | Total Deaths | 19 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: All Collected Deaths | On-treatment Deaths | 3 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: All Collected Deaths | Total Deaths | 14 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: All Collected Deaths | On-treatment Deaths | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: All Collected Deaths | Total Deaths | 11 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: All Collected Deaths | On-treatment Deaths | 2 Participants |
Secondary
Phase Ib and Phase II: Immunogenicity MCS110
Phase Ib and Phase II: Presence of anti-MCS110 antibodies
Time frame: 4 years
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment any positive | 1 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative | 6 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment all negative | 5 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment all negative | 10 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative | 11 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment all negative | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative | 11 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment all negative | 8 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment all negative | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative | 12 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive | 1 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment all negative | 6 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment only last positive | 1 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment all negative | 5 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative | 6 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative | 11 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment all negative | 6 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment all negative | 12 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative | 19 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative | 19 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment all negative | 16 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing | 4 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment all negative | 14 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative | 17 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing | 2 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative | 18 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline negative, on treatment all negative | 17 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline missing, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity MCS110 | Baseline positive, on treatment persistent positive | 0 Participants |
Secondary
Phase Ib and Phase II: Immunogenicity PDR001
Phase Ib and Phase II: Presence of anti-PDR001 antibodies
Time frame: 4 years
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment all negative | 4 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment any positive | 1 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative | 6 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment only last positive | 1 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment persistent positive | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment only last positive | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive | 2 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment any positive | 3 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment only last positive | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative | 10 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment persistent positive | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment all negative | 4 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment any positive | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative | 11 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment all negative | 8 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive | 2 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing | 1 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative | 10 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment all negative | 1 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment persistent positive | 1 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment all negative | 6 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment any positive | 1 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment all negative | 4 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative | 5 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive | 1 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment persistent positive | 1 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive | 2 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative | 8 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing | 1 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment any positive | 1 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment all negative | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment only last positive | 1 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment all negative | 2 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment any positive | 0 Participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment all negative | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment all negative | 11 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment all negative | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment any positive | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative | 18 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment any positive | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment all negative | 10 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment only last positive | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing | 2 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative | 17 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment only last positive | 4 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment only last positive | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing | 2 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment all negative | 16 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative | 19 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment persistent positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment persistent positive | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment any positive | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment all negative | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment any positive | 2 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative | 19 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment any positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment only last positive | 0 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline negative, on treatment all negative | 13 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline missing, on treatment all negative | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive | 1 Participants |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Immunogenicity PDR001 | Baseline positive, on treatment persistent positive | 0 Participants |
Secondary
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR)
Phase Ib and Phase II: PK Parameters - Accumulation ratio (AR), which is the AUClast (multiple Dose)/AUClast (single dose) (for cycle 4 only) - MCS110
Time frame: cycle 4 (day 84)
Population: Pharmacokinetic analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 0.789 Ratio of AUC | Standard Deviation 0.232 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 0.744 Ratio of AUC | Standard Deviation 0.307 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 0.833 Ratio of AUC | Standard Deviation 0.0739 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 1.14 Ratio of AUC | Standard Deviation 0.0991 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 1.37 Ratio of AUC | Standard Deviation 0.278 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 1.04 Ratio of AUC | Standard Deviation 0.731 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 0.712 Ratio of AUC | Standard Deviation 0.205 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 0.829 Ratio of AUC | Standard Deviation 0.177 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 0.723 Ratio of AUC | Standard Deviation 0.315 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) | 0.987 Ratio of AUC | Standard Deviation 0.35 |
Secondary
Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf
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
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples. There were some patients with AUClast but no AUCinf parameters because AUCinf could not be extrapolated from the data (i.e. the % of AUC extrapolated past the last time point is greater than 20% or the adjusted R squared parameter for the regression fit of the terminal phase of the PK profile is \< 0.75).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 4 - day 84 | 41000 day*ng/mL | Standard Deviation 22800 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 4 - day 84 | 42300 day*ng/mL | Standard Deviation 21900 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 1 - day 21 | 46900 day*ng/mL | Standard Deviation 9080 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 1 - day 21 | 50100 day*ng/mL | Standard Deviation 11600 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 1 - day 21 | 383000 day*ng/mL | Standard Deviation 178000 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 4 - day 84 | 260000 day*ng/mL | Standard Deviation 73500 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 4 - day 84 | 213000 day*ng/mL | Standard Deviation 92200 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 1 - day 21 | 343000 day*ng/mL | Standard Deviation 142000 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 4 - day 84 | 232000 day*ng/mL | Standard Deviation 99300 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 4 - day 84 | 253000 day*ng/mL | Standard Deviation 114000 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 1 - day 21 | 330000 day*ng/mL | Standard Deviation 73400 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 1 - day 21 | 249000 day*ng/mL | Standard Deviation 93400 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 4 - day 84 | 710000 day*ng/mL | Standard Deviation 171000 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 1 - day 21 | 560000 day*ng/mL | Standard Deviation 177000 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 1 - day 21 | 490000 day*ng/mL | Standard Deviation 149000 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 4 - day 84 | 619000 day*ng/mL | — |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 1 - day 21 | 909000 day*ng/mL | Standard Deviation 233000 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 1 - day 21 | 1020000 day*ng/mL | Standard Deviation 336000 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 4 - day 84 | 1520000 day*ng/mL | Standard Deviation 353000 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 4 - day 84 | 769000 day*ng/mL | — |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 1 - day 21 | 1090000 day*ng/mL | Standard Deviation 231000 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUCinf (day*ng/mL) - cycle 1 - day 21 | 988000 day*ng/mL | Standard Deviation 116000 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 4 - day 84 | 1200000 day*ng/mL | Standard Deviation 1030000 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 4 - day 84 | 1200000 day*ng/mL | Standard Deviation 389000 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 1 - day 21 | 1200000 day*ng/mL | Standard Deviation 507000 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 4 - day 84 | 918000 day*ng/mL | Standard Deviation 102000 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 1 - day 21 | 1090000 day*ng/mL | Standard Deviation 352000 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 1 - day 21 | 1120000 day*ng/mL | Standard Deviation 440000 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 4 - day 84 | 1010000 day*ng/mL | Standard Deviation 337000 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 1 - day 21 | 1270000 day*ng/mL | Standard Deviation 335000 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf | AUClast (day*ng/mL) - cycle 4 - day 84 | 1240000 day*ng/mL | Standard Deviation 499000 |
Secondary
Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL
Phase Ib and Phase II: PK Parameters - CL, which is the total body clearance of drug from the plasma (volume × time-1) - MCS110
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 4 - day 84 | 0.00117 L/h/kg | Standard Deviation 0.000549 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 1 - day 21 | 0.000863 L/h/kg | Standard Deviation 0.000158 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 4 - day 84 | 0.000523 L/h/kg | Standard Deviation 0.000199 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 1 - day 21 | 0.000388 L/h/kg | Standard Deviation 0.000181 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 1 - day 21 | 0.000394 L/h/kg | Standard Deviation 0.0000833 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 4 - day 84 | 0.000315 L/h/kg | Standard Deviation 0.000218 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 4 - day 84 | 0.000337 L/h/kg | — |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 1 - day 21 | 0.000407 L/h/kg | Standard Deviation 0.000131 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 1 - day 21 | 0.000338 L/h/kg | Standard Deviation 0.000117 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 4 - day 84 | 0.000541 L/h/kg | — |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL | CL (L/h/kg) - cycle 1 - day 21 | 0.000427 L/h/kg | Standard Deviation 0.0000558 |
Secondary
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast
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
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) - cycle 1 - day 21 | 17400 ng/mL | Standard Deviation 1870 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 1 - day 21 | 1120 ng/mL | Standard Deviation 795 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) -- cycle 4 - day 84 | 13500 ng/mL | Standard Deviation 5580 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 4 - day 84 | 510 ng/mL | Standard Deviation 457 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 1 - day 21 | 1290 ng/mL | Standard Deviation 2760 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) - cycle 1 - day 21 | 58800 ng/mL | Standard Deviation 16900 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 4 - day 84 | 5700 ng/mL | Standard Deviation 10300 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) -- cycle 4 - day 84 | 53000 ng/mL | Standard Deviation 9790 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 1 - day 21 | 6600 ng/mL | Standard Deviation 6370 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) - cycle 1 - day 21 | 56700 ng/mL | Standard Deviation 17800 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) -- cycle 4 - day 84 | 48900 ng/mL | Standard Deviation 14100 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 4 - day 84 | 3490 ng/mL | Standard Deviation 2410 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) - cycle 1 - day 21 | 96900 ng/mL | Standard Deviation 28600 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 1 - day 21 | 9130 ng/mL | Standard Deviation 11500 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) -- cycle 4 - day 84 | 76400 ng/mL | Standard Deviation 24000 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 4 - day 84 | 7350 ng/mL | Standard Deviation 5870 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) -- cycle 4 - day 84 | 176000 ng/mL | Standard Deviation 19800 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 1 - day 21 | 15100 ng/mL | Standard Deviation 9070 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 4 - day 84 | 45100 ng/mL | Standard Deviation 12400 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) - cycle 1 - day 21 | 122000 ng/mL | Standard Deviation 17100 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) -- cycle 4 - day 84 | 189000 ng/mL | Standard Deviation 29400 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 1 - day 21 | 28700 ng/mL | Standard Deviation 27800 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) - cycle 1 - day 21 | 186000 ng/mL | Standard Deviation 54000 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 4 - day 84 | 34100 ng/mL | Standard Deviation 29800 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 1 - day 21 | 33000 ng/mL | Standard Deviation 21300 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) -- cycle 4 - day 84 | 159000 ng/mL | Standard Deviation 39800 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 4 - day 84 | 57600 ng/mL | Standard Deviation 45000 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) - cycle 1 - day 21 | 158000 ng/mL | Standard Deviation 44800 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) - cycle 1 - day 21 | 130000 ng/mL | Standard Deviation 38400 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 4 - day 84 | 33300 ng/mL | Standard Deviation 42600 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 1 - day 21 | 12900 ng/mL | Standard Deviation 10700 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) -- cycle 4 - day 84 | 152000 ng/mL | Standard Deviation 58000 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 4 - day 84 | 18600 ng/mL | Standard Deviation 21700 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) - cycle 1 - day 21 | 134000 ng/mL | Standard Deviation 64900 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) -- cycle 4 - day 84 | 128000 ng/mL | Standard Deviation 42600 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 1 - day 21 | 24500 ng/mL | Standard Deviation 20100 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) -- cycle 4 - day 84 | 147000 ng/mL | Standard Deviation 38300 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Cmax (ng/mL) - cycle 1 - day 21 | 151000 ng/mL | Standard Deviation 42500 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 4 - day 84 | 29400 ng/mL | Standard Deviation 20700 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast | Clast (ng/mL) - cycle 1 - day 21 | 17500 ng/mL | Standard Deviation 11400 |
Secondary
Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2
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
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 4 - day 84 | 1.77 day |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 1 - day 21 | 1.5 day |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 4 - day 84 | 1.53 day |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 1 - day 21 | 2.16 day |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 1 - day 21 | 3.3 day |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 4 - day 84 | 4.08 day |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 4 - day 84 | 6.32 day |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 1 - day 21 | 3.48 day |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 1 - day 21 | 6.35 day |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 4 - day 84 | 4.82 day |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 | T1/2 (day) - cycle 1 - day 21 | 4.36 day |
Secondary
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax
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
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 1 - day 21 | 2.02 hour |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 4 - day 84 | 2 hour |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 1 - day 21 | 1.92 hour |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 4 - day 84 | 2.05 hour |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 1 - day 21 | 2.08 hour |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 4 - day 84 | 2.03 hour |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 1 - day 21 | 2.13 hour |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 4 - day 84 | 13 hour |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 4 - day 84 | 2 hour |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 1 - day 21 | 2.06 hour |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 4 - day 84 | 2.03 hour |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 1 - day 21 | 2.04 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 4 - day 84 | 2 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 1 - day 21 | 2.01 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 1 - day 21 | 2.08 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 4 - day 84 | 2.02 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 1 - day 21 | 2.09 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 4 - day 84 | 2.04 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 1 - day 21 | 2.08 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax | Tmax (h) - cycle 4 - day 84 | 2.05 hour |
Secondary
Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz
Phase Ib and Phase II: PK Parameters - Vz, which is the apparent volume of distribution during terminal phase (volume) - MCS110
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 4 - day 84 | 0.0684 L/kg | Standard Deviation 0.0407 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 1 - day 21 | 0.0486 L/kg | Standard Deviation 0.00989 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 4 - day 84 | 0.0294 L/kg | Standard Deviation 0.0128 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 1 - day 21 | 0.0334 L/kg | Standard Deviation 0.00783 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 1 - day 21 | 0.0423 L/kg | Standard Deviation 0.00875 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 4 - day 84 | 0.045 L/kg | Standard Deviation 0.0308 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 4 - day 84 | 0.0736 L/kg | — |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 1 - day 21 | 0.051 L/kg | Standard Deviation 0.0206 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 1 - day 21 | 0.0651 L/kg | Standard Deviation 0.0201 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 4 - day 84 | 0.0904 L/kg | — |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz | Vz (L/kg) - cycle 1 - day 21 | 0.065 L/kg | Standard Deviation 0.0267 |
Secondary
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR)
Phase Ib and Phase II: PK Parameters - Accumulation ratio (AR), which is the AUClast (multiple Dose)/AUClast (single dose) (for cycle 4 only) - PDR001
Time frame: cycle 4 (day 84)
Population: Pharmacokinetic analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 1.48 Ratio of AUC | Standard Deviation 0.17 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 1.15 Ratio of AUC | Standard Deviation 0.522 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 1.14 Ratio of AUC | Standard Deviation 0.176 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 1.89 Ratio of AUC | Standard Deviation 0.84 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 1.85 Ratio of AUC | Standard Deviation 0.348 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 1.5 Ratio of AUC | Standard Deviation 0.848 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 1.08 Ratio of AUC | Standard Deviation 0.235 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 1.56 Ratio of AUC | Standard Deviation 0.593 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 2.05 Ratio of AUC | Standard Deviation 0.156 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) | 1.54 Ratio of AUC | Standard Deviation 0.664 |
Secondary
Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf
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
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples. There were some patients with AUClast but no AUCinf parameters because AUCinf could not be extrapolated from the data (i.e. the % of AUC extrapolated past the last time point is greater than 20% or the adjusted R squared parameter for the regression fit of the terminal phase of the PK profile is \< 0.75).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 1 - day 21 | 229 day*ug/mL | Standard Deviation 68.3 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 4 - day 84 | 369 day*ug/mL | Standard Deviation 26.4 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUCinf (day*ug/mL) - cycle 4 - day 84 | 196 day*ug/mL | — |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 1 - day 21 | 271 day*ug/mL | Standard Deviation 53.8 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUCinf (day*ug/mL) - cycle 1 - day 21 | 274 day*ug/mL | — |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 4 - day 84 | 330 day*ug/mL | Standard Deviation 182 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 1 - day 21 | 651 day*ug/mL | Standard Deviation 322 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 4 - day 84 | 1020 day*ug/mL | Standard Deviation 526 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUCinf (day*ug/mL) - cycle 1 - day 21 | 610 day*ug/mL | — |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 1 - day 21 | 604 day*ug/mL | Standard Deviation 309 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 4 - day 84 | 2020 day*ug/mL | Standard Deviation 1170 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 4 - day 84 | 954 day*ug/mL | Standard Deviation 179 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUCinf (day*ug/mL) - cycle 1 - day 21 | 747 day*ug/mL | — |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 1 - day 21 | 581 day*ug/mL | Standard Deviation 147 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 1 - day 21 | 450 day*ug/mL | Standard Deviation 135 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUCinf (day*ug/mL) - cycle 1 - day 21 | 710 day*ug/mL | — |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 4 - day 84 | 718 day*ug/mL | Standard Deviation 288 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 1 - day 21 | 825 day*ug/mL | Standard Deviation 402 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 4 - day 84 | 1170 day*ug/mL | Standard Deviation 388 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 1 - day 21 | 782 day*ug/mL | Standard Deviation 264 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 4 - day 84 | 1330 day*ug/mL | Standard Deviation 555 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 1 - day 21 | 764 day*ug/mL | Standard Deviation 311 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 4 - day 84 | 1660 day*ug/mL | Standard Deviation 283 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 4 - day 84 | 1260 day*ug/mL | Standard Deviation 533 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf | AUClast (day*ug/mL) - cycle 1 - day 21 | 782 day*ug/mL | Standard Deviation 307 |
Secondary
Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL
Phase Ib and Phase II: PK Parameters - CL, which is the total body clearance of drug from the plasma (volume × time-1) - PDR001
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL | CL (L/h) - cycle 1 - day 21 | 0.0152 L/h |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL | CL (L/h) - cycle 4 - day 84 | 0.0213 L/h |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL | CL (L/h) - cycle 1 - day 21 | 0.0205 L/h |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL | CL (L/h) - cycle 1 - day 21 | 0.0167 L/h |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL | CL (L/h) - cycle 1 - day 21 | 0.0176 L/h |
Secondary
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast
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
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) - cycle 1 - day 21 | 24 ug/mL | Standard Deviation 9.52 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 1 - day 21 | 7.73 ug/mL | Standard Deviation 2.97 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) -- cycle 4 - day 84 | 29.5 ug/mL | Standard Deviation 9.3 |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 4 - day 84 | 10.7 ug/mL | Standard Deviation 2.25 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 1 - day 21 | 7.24 ug/mL | Standard Deviation 2.95 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) - cycle 1 - day 21 | 29.5 ug/mL | Standard Deviation 6.56 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 4 - day 84 | 14.5 ug/mL | Standard Deviation 8.47 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) -- cycle 4 - day 84 | 36.8 ug/mL | Standard Deviation 10.5 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 1 - day 21 | 19.4 ug/mL | Standard Deviation 11.7 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) - cycle 1 - day 21 | 73.4 ug/mL | Standard Deviation 22.3 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) -- cycle 4 - day 84 | 126 ug/mL | Standard Deviation 54.6 |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 4 - day 84 | 65.1 ug/mL | Standard Deviation 37.6 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) - cycle 1 - day 21 | 77 ug/mL | Standard Deviation 24.3 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 1 - day 21 | 26.4 ug/mL | Standard Deviation 11.8 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) -- cycle 4 - day 84 | 153 ug/mL | Standard Deviation 22.6 |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 4 - day 84 | 71 ug/mL | Standard Deviation 6.65 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) -- cycle 4 - day 84 | 92 ug/mL | Standard Deviation 22.1 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 1 - day 21 | 22.7 ug/mL | Standard Deviation 12.8 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 4 - day 84 | 47.5 ug/mL | Standard Deviation 25.7 |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) - cycle 1 - day 21 | 76.6 ug/mL | Standard Deviation 36.8 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) -- cycle 4 - day 84 | 85.9 ug/mL | Standard Deviation 16.8 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 1 - day 21 | 17.2 ug/mL | Standard Deviation 8.67 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) - cycle 1 - day 21 | 64.2 ug/mL | Standard Deviation 20.4 |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 4 - day 84 | 35.6 ug/mL | Standard Deviation 14.7 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 1 - day 21 | 34.5 ug/mL | Standard Deviation 13.3 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) -- cycle 4 - day 84 | 123 ug/mL | Standard Deviation 56.8 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 4 - day 84 | 81.4 ug/mL | Standard Deviation 43.6 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) - cycle 1 - day 21 | 94.5 ug/mL | Standard Deviation 27.4 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) - cycle 1 - day 21 | 75.3 ug/mL | Standard Deviation 23.9 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 4 - day 84 | 62.1 ug/mL | Standard Deviation 9.93 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 1 - day 21 | 24 ug/mL | Standard Deviation 12 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) -- cycle 4 - day 84 | 127 ug/mL | Standard Deviation 7 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 4 - day 84 | 48.8 ug/mL | Standard Deviation 20.6 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) - cycle 1 - day 21 | 80.2 ug/mL | Standard Deviation 24 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) -- cycle 4 - day 84 | 122 ug/mL | Standard Deviation 23.6 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 1 - day 21 | 22.8 ug/mL | Standard Deviation 9.44 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) -- cycle 4 - day 84 | 108 ug/mL | Standard Deviation 23.4 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Cmax (ug/mL) - cycle 1 - day 21 | 70.3 ug/mL | Standard Deviation 21.6 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 4 - day 84 | 51.3 ug/mL | Standard Deviation 23.7 |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast | Clast (ug/mL) - cycle 1 - day 21 | 24.4 ug/mL | Standard Deviation 14.6 |
Secondary
Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2
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
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 | T1/2 (day) - cycle 1 - day 21 | 8.14 day |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 | T1/2 (day) - cycle 4 - day 84 | 7.81 day |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 | T1/2 (day) - cycle 1 - day 21 | 7.71 day |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 | T1/2 (day) - cycle 1 - day 21 | 7.13 day |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 | T1/2 (day) - cycle 1 - day 21 | 7.33 day |
Secondary
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax
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
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 1 - day 21 | 11.5 hour |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 4 - day 84 | 1.52 hour |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 1 - day 21 | 2.08 hour |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 4 - day 84 | 1.53 hour |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 1 - day 21 | 1.53 hour |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 4 - day 84 | 1.2 hour |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 1 - day 21 | 1.57 hour |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 4 - day 84 | 1.57 hour |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 4 - day 84 | 1.5 hour |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 1 - day 21 | 1.53 hour |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 4 - day 84 | 1.45 hour |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 1 - day 21 | 1.52 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 4 - day 84 | 1.53 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 1 - day 21 | 1.5 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 1 - day 21 | 1.5 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 4 - day 84 | 1.47 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 1 - day 21 | 1.5 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 4 - day 84 | 1.54 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 1 - day 21 | 1.5 hour |
| Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax | Tmax (h) - cycle 4 - day 84 | 1.5 hour |
Secondary
Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz
Phase Ib and Phase II: PK Parameters - Vz, which is the apparent volume of distribution during terminal phase (volume) - PDR001
Time frame: cycle 1 (day 21) and cycle 4 (day 84)
Population: Pharmacokinetic analysis set. Some patients were excluded from the PK parameter analysis because of missed visits, missed sampling, early termination, dosing outside the planned dose, or lost samples.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz | Vz (L) - cycle 1 - day 21 | 4.28 Liters (L) |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz | Vz (L) - cycle 4 - day 84 | 5.76 Liters (L) |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz | Vz (L) - cycle 1 - day 21 | 5.47 Liters (L) |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz | Vz (L) - cycle 1 - day 21 | 4.13 Liters (L) |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz | Vz (L) - cycle 1 - day 21 | 4.47 Liters (L) |
Secondary
Phase Ib: Overall Response Rate (ORR)
Phase Ib: Overall Response Rate (Complete response (CR) or Partial response (PR)), per RECIST v1.1 and per immune related Response criteria (irRC)
Time frame: 4 years
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate as per investigator based on RECIST v1.1 | 16.7 Percentage of participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate - as per investigator based on irRC | 16.7 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate as per investigator based on RECIST v1.1 | 0 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate - as per investigator based on irRC | 0 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate as per investigator based on RECIST v1.1 | 0 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate - as per investigator based on irRC | 0 Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate as per investigator based on RECIST v1.1 | 0 Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate - as per investigator based on irRC | 0 Percentage of participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate as per investigator based on RECIST v1.1 | 0 Percentage of participants |
| Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate - as per investigator based on irRC | 0 Percentage of participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate as per investigator based on RECIST v1.1 | 9.1 Percentage of participants |
| Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W | Phase Ib: Overall Response Rate (ORR) | Overall Response Rate - as per investigator based on irRC | 9.1 Percentage of participants |
Secondary
Phase II: Bayesian Inference of Clinical Benefit Rate - Per irRC - Mean
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)
Time frame: 4 years
Population: Full Analysis Set. Since objective responses are rare in advanced pancreatic cancer and that long lasting stable disease is considered beneficial to patients, clinical benefit rate (confirmed objective response or SD\>4 months) was used as the primary endpoint for antitumor activity in this study changed from objective response to for this patient population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Bayesian Inference of Clinical Benefit Rate - Per irRC - Mean | NA Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Bayesian Inference of Clinical Benefit Rate - Per irRC - Mean | 5.6 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Bayesian Inference of Clinical Benefit Rate - Per irRC - Mean | NA Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Bayesian Inference of Clinical Benefit Rate - Per irRC - Mean | NA Percentage of participants |
Secondary
Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean
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)
Time frame: 4 years
Population: Full Analysis Set. Since objective responses are rare in advanced pancreatic cancer and that long lasting stable disease is considered beneficial to patients, clinical benefit rate (confirmed objective response or SD\>4 months) was used as the primary endpoint for antitumor activity in this study changed from objective response to for this patient population.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean | 6.7 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean | NA Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean | 10.8 Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean | 0.8 Percentage of participants |
Secondary
Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC
Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) \> 4 month)) per immune related Response criteria (irRC)
Time frame: 4 years
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC | 20.0 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC | 5.0 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC | 19.0 Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC | 30.0 Percentage of participants |
Secondary
Phase II : Overall Response Rate (ORR) - Per irRC
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)
Time frame: 4 years
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II : Overall Response Rate (ORR) - Per irRC | 5 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II : Overall Response Rate (ORR) - Per irRC | 0 Percentage of participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II : Overall Response Rate (ORR) - Per irRC | 9.5 Percentage of participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II : Overall Response Rate (ORR) - Per irRC | 0 Percentage of participants |
Secondary
Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety
Phase II: To further characterize the safety and tolerability of MCS110 given in combination with PDR001
Time frame: From start of treatment to a maximum timeframe of 92.4 weeks for phase II.
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - all grades | 20 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - Treatment-related - all grades | 16 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - all grades | 8 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - Treatment-related - all grades | 1 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - all grades | 1 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - all grades | 1 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - Treatment-related - all grades | 1 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to dose adjustment / interruption - all grades | 11 Participants |
| Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs requiring additional therapy - all grades | 19 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - all grades | 14 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to dose adjustment / interruption - all grades | 4 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - Treatment-related - all grades | 4 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - all grades | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - Treatment-related - all grades | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - all grades | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs requiring additional therapy - all grades | 18 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - all grades | 20 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - Treatment-related - all grades | 15 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - Treatment-related - all grades | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - all grades | 1 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs requiring additional therapy - all grades | 19 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - all grades | 21 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - Treatment-related - all grades | 4 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to dose adjustment / interruption - all grades | 8 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - Treatment-related - all grades | 17 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - all grades | 0 Participants |
| Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - all grades | 8 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - all grades | 1 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - Treatment-related - all grades | 1 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Fatal SAEs - Treatment-related - all grades | 0 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs requiring additional therapy - all grades | 17 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to discontinuation - all grades | 2 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - Treatment-related - all grades | 19 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - all grades | 7 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | SAEs - Treatment-related - all grades | 1 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | Adverse events - all grades | 20 Participants |
| Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W | Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety | AEs leading to dose adjustment / interruption - all grades | 11 Participants |