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Chemotherapy

Chemotherapy + Pembrolizumab/Olaparib for Ovarian Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female participants are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.) Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the Treatment Period and for at least 120 days following the last dose of pembrolizumab (or pembrolizumab placebo) and bevacizumab (if administered), at least 180 days following the last dose of olaparib (or olaparib placebo), and at least 210 days following the last dose of chemotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy test within either 24 hours (urine) or 72 hours (serum) before the first dose of study treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is required. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Has histologically confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid (any grade), carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer

Must not have

Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.

Either has had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 6 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

Summary

This trial is testing a new combination of drugs to treat ovarian cancer. The new combination is pembrolizumab, carboplatin/paclitaxel, and maintenance olaparib. The hypothesis is that this new combination will be better than just carboplatin/paclitaxel at treating ovarian cancer.

Who is the study for?

This trial is for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. They should be candidates for specific chemotherapy, have adequate organ function, and not be pregnant or breastfeeding. Women must use effective contraception and provide a biopsy before randomization.

What is being tested?

The study tests if adding pembrolizumab to carboplatin/paclitaxel chemotherapy followed by olaparib maintenance improves progression-free survival in these patients compared to chemotherapy alone. It's specifically for those without BRCA mutations but with PD-L1-positive tumors.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs used, fatigue, blood disorders like anemia or clotting issues, digestive problems such as nausea or diarrhea, increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant or breastfeeding and follow the required contraceptive guidelines.

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My cancer is advanced ovarian, peritoneal, or fallopian tube cancer.

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I can provide a recent biopsy for BRCA1/2 and PD-L1 testing.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am eligible for carboplatin and paclitaxel chemotherapy before or after surgery.

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My CA-125 to CEA ratio is 25 or higher, and I am a candidate for initial chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I had major surgery less than 3 weeks ago or am still recovering from one.

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My heart test shows uncontrolled conditions or I have a long QT syndrome.

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My ovarian tumor is mucinous, germ cell, or borderline.

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I am experiencing severe side effects from recent chemotherapy, except for hair loss.

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I have been treated with specific immune therapy for cancer.

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I have received drugs to boost my white blood cells within the last 4 weeks.

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I have had treatment for ovarian cancer, including radiation or chemotherapy.

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I am highly allergic to pembrolizumab, olaparib, carboplatin, paclitaxel, bevacizumab or their ingredients.

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I have received an organ or tissue transplant from a donor.

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I am currently being treated for an infection.

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I am receiving or planning to receive chemotherapy directly into my abdomen as my first treatment.

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I have been treated with olaparib or another PARP inhibitor before.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I have an active tuberculosis infection.

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I have or had lung inflammation treated with steroids.

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I cannot take pills by mouth or have a condition that affects how my body absorbs medication.

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I have bowel issues due to my ovarian cancer and am receiving bevacizumab.

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I have a harmful BRCA1 or BRCA2 gene mutation.

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I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.

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I am taking strong or moderate drugs that affect liver enzymes and can't stop them for the study.

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I am taking medication that strongly affects my liver and cannot stop during the study.

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I haven't had any bleeding issues in the past 6 months.

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My high blood pressure is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants with Programmed Death-Ligand 1 (PD-L1)-Positive Tumors (Combined Positive Score [CPS]≥10)

Secondary study objectives

Mean Change from Baseline in Abdominal and Gastrointestinal (Abdominal/GI) Symptoms Score Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale

Mean Change from Baseline in Global Health Status/Quality of Life (GHS/QoL) Score Using Questions from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)

Number of Participants Who Discontinue Study Treatment Due to an AE

+13 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + Placebo for OlaparibExperimental Treatment6 Interventions

Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles starting in Cycle 1 PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Group II: Pembrolizumab + OlaparibExperimental Treatment6 Interventions

Participants receive carboplatin/paclitaxel via intravenous (IV) infusion for five 3-week cycles PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS olaparib 300 mg via oral tablet twice each day (BID), starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Group III: Placebo for Pembrolizumab + Placebo for OlaparibActive Control6 Interventions

Participants receive carboplatin/paclitaxel via IV infusion for five 3-week cycles PLUS placebo for pembrolizumab (normal saline or dextrose) via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles PLUS placebo for olaparib via oral tablet BID, starting with Cycle 7. Participants who experience severe hypersensitivity reaction to paclitaxel or an AE requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 Q3W) plus carboplatin AUC 5 Q3W after Sponsor consultation. Participants may also receive bevacizumab via IV infusion on Day 1 of each 3-week cycle at the Investigator's discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

FDA approved

Olaparib

FDA approved

Pembrolizumab

FDA approved

Docetaxel

FDA approved