Phase Ib/II Study of Carboplatin + M6620 + Avelumab in PARPi-resistant Ovarian Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

March 4, 2019

Primary Completion Date

November 6, 2019

Study Completion Date

November 6, 2019

Conditions
Ovarian Cancer
Interventions
DRUG

M6620

Participants received 90 milligrams per square meter (mg/m\^2) of M6620, intravenously (IV) on Day 2 of every 3 weeks (Q3W) cycle for a maximum of 6 cycles in combination treatment with carboplatin and avelumab on Day 1. The M6620 dose may be de-escalated to 60 mg/m\^2, or 40 mg/m\^2.

DRUG

Avelumab

Participants received IV infusion of avelumab 1600 mg on Day 1 of each Q3W cycle for maximum of 6 cycles in combination treatment with carboplatin and M6620. Thereafter, avelumab 800 mg intravenously on Day 1 of every two weeks as a maintenance mono-therapy until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.

DRUG

Carboplatin

Participants received carboplatin area under the concentration-time curve 5 on Day 1 of each Q3W cycle for a maximum of 6 cycles in combination treatment with avelumab and M6620.

Trial Locations (13)

11041

Mount Sinai - PRIME, New York

48604

Covenant Health Care, Saginaw

73104

Peggy & Charles Stephenson Oklahoma Cancer Ctr, Oklahoma City

75251

Mary Crowley Cancer Research Centers, Dallas

94904

Marin Cancer Care, Inc., Greenbrae

06904

The Stamford Hospital, Stamford

10065-6007

Memorial Sloan Kettering Cancer Center, New York

Unknown

UZ Leuven, Leuven

CHU Sart Tilman, Liège

GZA Ziekenhuizen - Campus Sint-Augustinus, Wilrijk

Royal Cornwall Hospital, Truro

Royal Marsden Hospital, Sutton

Royal Marsden Hospital, London

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT03704467 - Phase Ib/II Study of Carboplatin + M6620 + Avelumab in PARPi-resistant Ovarian Cancer | Biotech Hunter | Biotech Hunter