Neoplasm malignant
Conditions
Brief summary
Clinical Benefit - Cohort A, Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator – Cohort B
Detailed description
Pathologic Complete Response (pCR) – Cohort A, Major Pathologic Response (mPR) - Cohort A, ORR per RECIST 1.1 as assessed by Investigator - Cohort A, Number of participants with an adverse event (AE) - Cohorts A and B, Number of participants discontinuing from study therapy due to AE - Cohorts A and B, Number of participants experiencing perioperative complications - Cohort A, Number of participants with an AE that precludes surgery - Cohort A
Interventions
Sponsors
Merck Sharp & Dohme LLC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Benefit - Cohort A, Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Investigator – Cohort B | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response (pCR) – Cohort A, Major Pathologic Response (mPR) - Cohort A, ORR per RECIST 1.1 as assessed by Investigator - Cohort A, Number of participants with an adverse event (AE) - Cohorts A and B, Number of participants discontinuing from study therapy due to AE - Cohorts A and B, Number of participants experiencing perioperative complications - Cohort A, Number of participants with an AE that precludes surgery - Cohort A | — |
Countries
France, Germany, Italy, Netherlands
Outcome results
None listed