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Phase Ib and Phase II Studies of MK-3475 in Combination + for Renal Cell Carcinoma:

NCT02348008 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2022-09-14

Study results available
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Summary

This is an open label, multi-institutional, single arm study of dose escalation phase Ib cohort, followed by a phase II cohort of anti-PD-1 antibody MK-3475 in combination with bevacizumab. No randomization or blinding is involved.

Conditions

  • Clear Cell Renal Carcinoma

Interventions

DRUG

MK-3475

Arm A: Phase 1b Cohort 1: 200mg IV; Arm A: Phase 1b Cohort 2: 200mg IV

DRUG

Bevacizumab

Arm A: Phase 1b Cohort 1: 10mg IV; Arm A: Phase 1b Cohort 2: 15mg IV

DRUG

MK-3475

Arm B: Phase II Treatment: 200mg IV

DRUG

Bevacizumab

Arm B: Phase II Treatment: administered at the maximum safe dose of 10mg or 15mg as established in the Phase 1b dose escalation cohort study.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Big Ten Cancer Research Consortium

    collaborator OTHER

  • Arkadiusz Z. Dudek, MD

    lead OTHER

Principal Investigators

  • Arkadiusz Z Dudek, M.D., Ph.D. · Big Ten Cancer Research Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-12-05
Completion
2019-12-05

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02348008 on ClinicalTrials.gov