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



Status:Recruiting
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:March 4, 2019
End Date:November 24, 2021
Contact:US Medical Information
Email:service@emdgroup.com
Phone:888-275-7376

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A Phase Ib Safety Run-in and Randomized Phase II, Open-label Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of M6620 in Combination With Avelumab and Carboplatin in Comparison to Standard of Care Therapy in Participants With PARPi-resistant Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

The study is to evaluate the efficacy and safety of avelumab in combination with M6620 +
carboplatin in participants with PARPi-resistant, recurrent, platinum sensitive ovarian,
primary peritoneal, or fallopian tube cancer.


Inclusion Criteria:

- Female participants with recurrent epithelial ovarian cancer who have disease
progression following maintenance treatment with a PARPi as defined below:

1. Participant must have histologically diagnosed epithelial ovarian, primary
peritoneal, or fallopian tube cancer, with nonmucinous histology

2. Participants must have completed at least 2 previous courses of platinum
containing therapy (for example, carboplatin or cisplatin) and had documented
response (complete response [CR] or partial response [PR]) to the last
platinum-based treatment prior to treatment with a PARPi

3. Participant has received the last dose of platinum-containing treatment at least
6 months prior to study enrollment

4. Participant has documented disease progression (radiological) after at least 4
months of maintenance treatment with PARPi following a response to platinum-based
chemotherapy.

- Confirmed breast cancer gene (BRCA) 1/2 mutation status or agree to its testing on
samples collected in the study.

- Available formalin-fixed, paraffin-embedded (FFPE) tumor biopsies.

- Part A: Optional 2 paired on-treatment biopsies on Day 2 of Cycle 1 (first biopsy) and
Day 2 of Cycle 1 or Cycle 2 (second biopsy) respectively, before and after M6620
administration, if assessed as feasible at low risk by the interventional radiologist.

- Part B: Histological tissue specimen (tissue block or 8 to 10 unstained slides) must
be available. An archival tumor biopsy is acceptable if obtained after the last
progression on PARPi treatment and is less than 4 months old. Otherwise, participants
must be willing to undergo mandatory biopsy during the Screening Period to obtain
sufficient tissue for histological assessment. Participants need to have an attempted
biopsy. However, participants who have measurable disease documented by a radiologist
as not feasible or safe to be biopsied are eligible to enter the study

- Measurable disease according to RECIST v1.1.

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- Treatment with a nonpermitted drug/intervention as listed below:

1. Concurrent anticancer treatment (e.g., cytoreductive therapy, radiotherapy,
immune therapy, cytokine therapy, monoclonal antibody, or targeted small molecule
therapy) or any study intervention within 4 weeks prior to start of study
intervention, or not recovered from AEs related to such therapies

2. History of prior dose reductions or dose interruptions while receiving cisplatin
or carboplatin due to toxicity from the platinum or intolerance to either agent,
unless discussed with and approved by the Sponsor Medical Monitor

3. Prior treatment with a PD-1/PD-L1 targeting agent

- Current use of the following medications at the time of enrollment:

1. Immunotherapy or immunosuppressive drugs at the time of enrollment (for example
(e.g.,) chemotherapy or systemic corticosteroids) EXCEPT for (a) intranasal,
inhaled, topical steroids, or local steroid injection (e.g., intra articular
injection), (b) systemic corticosteroids at physiologic doses less than or equals
to (≤) 10 milligram per day (mg/day) of prednisone or equivalent, (c) steroids as
premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan
premedication)

2. Growth factors EXCEPT where indicated for treatment of study intervention related
myelosuppression and for prophylaxis of repeat myelosuppression after initial
occurrence

3. Herbal remedies with immunostimulating properties (e.g., mistletoe extract) or
known to potentially interfere with major organ function (e.g., hypericin)

4. Other DNA damage repair inhibitors (except PARPi) (e.g., inhibitors of ATR,
ataxia telangiectasia mutated [ATM] kinase, DNA-dependent protein kinase
[DNA-PK], or Wee kinases).

- Other protocol defined exclusion criteria could apply
We found this trial at
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Greenbrae, California 94904
Principal Investigator: Peter Eisenberg
Phone: 415-925-5040
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Birmingham, Alabama 35294
Principal Investigator: Rebecca Arend
Phone: 205-934-6454
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Anchorage, Alaska 99508
Principal Investigator: Melissa Hardesty
Phone: 907-212-4732
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Augusta, Georgia 30912
Principal Investigator: Sharad Ghamande
Phone: 706-721-8978
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Joyce Liu
Phone: 617-632-4274
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Bronx, New York 10467
Principal Investigator: Nicole Nevadunsky
Phone: 718-405-8434
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Dallas, Texas 75246
Principal Investigator: Minal Barve
Phone: 214-658-1994
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Edegem, 2650
Principal Investigator: Konstantinos Papadimitriou,
Phone: 3238215589
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Fayetteville, Arkansas 72703
Principal Investigator: Joseph Beck
Phone: 479-878-5441
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30 Prospect Avenue
Hackensack, New Jersey 07601
Principal Investigator: Donna McNamara
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Los Angeles, California 90048
Principal Investigator: Bobbie Rimel
Phone: 310-423-3348
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Rachael Grisham
Phone: 646-888-0928
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, New York 10029
Principal Investigator: Stephanie Blank
Phone: 516-470-6911
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Oklahoma City, Oklahoma 73104
Principal Investigator: Camille Gunderson
Phone: 405-271-8777
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Providence, Rhode Island 02095
Principal Investigator: Cara Mathews
Phone: 401-274-1122
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Saginaw, Michigan
Principal Investigator: Gregory Sutton
Phone: 989-583-6364
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Scarborough, Maine 04074
Principal Investigator: Christopher Darus
Phone: 207-396-8376
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Stamford, Connecticut 06904
Principal Investigator: Salvatore Del Prete
Phone: 203-276-8453
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