Phase Ib/II Study of Carboplatin + M6620 + Avelumab in PARPi-resistant Ovarian Cancer
NCT ID: NCT03704467
Last Updated: 2020-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
3 participants
INTERVENTIONAL
2019-03-04
2019-11-06
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part A: Carboplatin + M6620 + Avelumab
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Exclusion Criteria
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).
18 Years
FEMALE
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Marin Cancer Care, Inc.
Greenbrae, California, United States
The Stamford Hospital
Stamford, Connecticut, United States
Covenant Health Care
Saginaw, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Mount Sinai - PRIME
New York, New York, United States
Peggy & Charles Stephenson Oklahoma Cancer Ctr
Oklahoma City, Oklahoma, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, United States
UZ Leuven
Leuven, , Belgium
CHU Sart Tilman
Liège, , Belgium
GZA Ziekenhuizen - Campus Sint-Augustinus
Wilrijk, , Belgium
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2018-001534-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS201943_0029
Identifier Type: -
Identifier Source: org_study_id