Trial · NCT02807844
Registered outcomes41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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) |
| Primary | 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) |
| Primary | 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 |
| Primary | 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 |
| Primary | 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). |
| Primary | 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). |
| Primary | 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). |
| Primary | 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). |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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) |
| 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 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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