Phase 2
Completed N=141
Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
Source: ClinicalTrials.gov NCT02807844 ↗Enrolled (actual)
141
Serious AEs
44.0%
Results posted
Aug 2021
Primary outcomePrimary: Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety — 6; 12; 12; 13 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety |
6; 12; 12; 13; 6; 11 | — |
| PRIMARY Phase II : Overall Response Rate (ORR) - Per RECIST v1.1 |
5; 0; 9.5; 0 | — |
| PRIMARY Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean |
6.7; NA; 10.8; 0.8 | — |
| PRIMARY Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1 |
20; 0; 9.5; 10.0 | — |
| PRIMARY Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean |
NA; 0.8; NA; NA | — |
| PRIMARY Phase Ib: Planned Dose Intensity - MCS110 |
0.86; 2.74; 2.66; 4.85; 7.05; 9.47 | — |
| PRIMARY Phase Ib: Relative Dose Intensity - MCS110 |
100; 100; 100; 99.23; 100; 100 | — |
| PRIMARY Phase Ib: Planned Dose Intensity - PDR001 |
86.09; 91.18; 265.83; 293.59; 282.12; 289.04 | — |
| PRIMARY Phase Ib: Relative Dose Intensity - PDR001 |
100.00; 100.00; 100.00; 100.00; 100.00; 100.00 | — |
| PRIMARY Phase Ib: Number of Participants With Dose Reductions |
6; 12; 12; 13; 6; 9 | — |
| PRIMARY Phase Ib: Number of Dose Interruptions Per Participant |
1.3; 0.3; 0.3; 0.0; 0.3; 0.1 | — |
| PRIMARY Phase Ib: Number of Subjects With at Least One Dose Interruption |
3; 3; 3; 0; 2; 1 | — |
| PRIMARY Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY Phase II : Overall Response Rate (ORR) - Per irRC |
5; 0; 9.5; 0 | — |
| SECONDARY Phase Ib: Overall Response Rate (ORR) |
16.7; 0; 0; 0; 0; 9.1 | — |
| SECONDARY Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean |
6.7; NA; 10.8; 0.8 | — |
| SECONDARY Phase 1b: Clinical Benefit Rate (CBR) |
33.3; 8.3; 0; 0; 0; 18.2 | — |
| SECONDARY Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC |
20.0; 5.0; 19.0; 30.0 | — |
| SECONDARY Phase II: Bayesian Inference of Clinical Benefit Rate - Per irRC - Mean |
NA; 5.6; NA; NA | — |
| 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 |
1.5; 1.3; 1.3; 1.1; 1.3; 1.2 | — |
| SECONDARY Phase 1b and Phase II: Overall Survival - Using Kaplan-Meier Method - Median |
12.3; 9.6; 4.2; 2.8; 22.8; 5.7 | — |
| SECONDARY Phase 1b and Phase II: Duration of Response (DOR) |
372.0; NA; NA; NA; NA; 155.0 | — |
| SECONDARY Phase 1b and Phase II: Disease Control Rate (DCR) |
33.3; 8.3; 0; 15.4; 16.7; 18.2 | — |
| SECONDARY Phase II: Percentage of Participants With Adverse Events, as a Measure of Safety |
20; 20; 21; 20; 16; 15 | — |
| SECONDARY Phase Ib and Phase II: Immunogenicity MCS110 |
0; 1; 1; 1; 0; 0 | — |
| SECONDARY Phase Ib and Phase II: Immunogenicity PDR001 |
0; 2; 1; 2; 1; 2 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of MCS110 - AUClast and AUCinf |
46900; 343000; 249000; 490000; 909000; 1090000 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of PDR001 - AUClast and AUCinf |
229; 271; 651; 604; 581; 450 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of MCS110 - Cmax and Clast |
17400; 58800; 56700; 96900; 122000; 186000 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of PDR001 - Cmax and Clast |
24; 29.5; 73.4; 77; 76.6; 64.2 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of MCS110 - Tmax |
2.02; 1.92; 2.08; 2.13; 2.06; 2.04 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of PDR001 - Tmax |
11.5; 2.08; 1.53; 1.57; 1.53; 1.52 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of MCS110 - T1/2 |
1.5; 2.16; 3.3; 3.48; 6.35; 4.36 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of PDR001 - T1/2 |
8.14; 7.71; 7.13; 7.33; 7.81 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of MCS110 - CL |
0.000863; 0.000388; 0.000394; 0.000407; 0.000338; 0.000427 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of PDR001 - CL |
0.0152; 0.0205; 0.0167; 0.0176; 0.0213 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of MCS110 - Vz |
0.0486; 0.0334; 0.0423; 0.051; 0.0651; 0.065 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of PDR001 - Vz |
4.28; 5.47; 4.13; 4.47; 5.76 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of MCS110 - Accumulation Ratio (AR) |
0.789; 0.744; 0.833; 1.14; 1.37; 1.04 | — |
| SECONDARY Phase Ib and Phase II: Pharmacokinetics of PDR001 - Accumulation Ratio (AR) |
1.48; 1.15; 1.14; 1.89; 1.85; 1.5 | — |
| SECONDARY Phase Ib and Phase II: All Collected Deaths |
6; 12; 10; 12; 4; 10 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02807844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.