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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Arkadiusz Z. Dudek, MD
Study ID
NCT02348008
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Clear Cell Renal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-3475 — DRUG
    Arm A: Phase 1b Cohort 1: 200mg IV; Arm A: Phase 1b Cohort 2: 200mg IV
  • Bevacizumab — DRUG
    Arm A: Phase 1b Cohort 1: 10mg IV; Arm A: Phase 1b Cohort 2: 15mg IV
  • MK-3475 — DRUG
    Arm B: Phase II Treatment: 200mg IV
  • Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jan 28, 2015
Start date
Mar 31, 2015
Status verified
Aug 2022
Primary completion
Dec 5, 2019
Completion
Dec 5, 2019

Study Design

Enrollment
61 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - Phase 1b Dose Escalation Cohort
    Cohort 1 will consist of 3-6 patients who will receive MK-3475 200mg and bevacizumab 10mg on day 1 of the 21-day cycle. The drugs are administered 15-30 minutes apart in separate intravenous infusions. Cohort 2 will consist of 3-9 patients who will receive MK-3475 200mg and bevacizumab 15mg on day 1 of the 21-day cycle. The drugs are administered 15-30 minutes apart in separate intravenous infusions. If none of the 3 subjects experience a dose limiting toxicity (DLT) during the first cycle of therapy, an additional 3 subjects will be enrolled at dose level 2. If all three subjects in dose level 2 complete the first cycle of therapy without DLT, 3 more subjects will be enrolled to ensure only 0-1 of 6 subjects have a DLT. There will be no further escalation beyond dose level 2.
  • Other: Arm B - Phase II Investigational Treatment
    The maximum safe dose of MK-3475 in combination bevacizumab (as determined in the phase 1b cohort) will be given on day 1 of each 21 day cycle.

Primary Outcome Measure

Phase 1b: Maximum Safe Dose of Treatment Regimen [ Time Frame: Every 21 days while on treatment (estimated 4 months) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Northwestern University, Robert H. Lurie Cancer CenterChicagoIllinois60611-
University of Illinois Cancer CenterChicagoIllinois60612-
University of Iowa, Holden Comprehensive Cancer CenterIowa CityIowa52242-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Michigan State University, Breslin Cancer CenterLansingMichigan48910-
University of Minnesota: Masonic Cancer CenterMinneapolisMinnesota55455-
University of Nebraska, Fred and Pamela Buffet Cancer CenterOmahaNebraska68198-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Penn State Hershey Cancer InstituteHersheyPennsylvania17033-

Find similar trials in Chicago, IL

By research site
Northwestern University, Robert H. Lurie Cancer Center· Chicago, ILUniversity of Illinois Cancer Center· Chicago, ILUniversity of Iowa, Holden Comprehensive Cancer Center· Iowa City, IAUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIMichigan State University, Breslin Cancer Center· Lansing, MIUniversity of Minnesota: Masonic Cancer Center· Minneapolis, MN

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