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Alkylating agents

Immunotherapy + Chemotherapy for Ovarian Cancer

Phase 2

Waitlist Available

Led By Amir Jazaeri, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer

No more than 4 prior cycles of chemotherapy for primary advanced (stage III or IV) epithelial ovarian, primary peritoneal, or fallopian tube cancer

Must not have

Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

Patients with ovarian cancer not medically fit for diagnostic laparoscopy prior to initiation of therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of immunotherapy and chemotherapy to see if it is more effective in treating ovarian, primary peritoneal, or fallopian tube cancer than chemotherapy alone.

Who is the study for?

This trial is for patients with advanced stage III-IV ovarian, primary peritoneal, or fallopian tube cancer. Eligible participants can have had up to four prior chemo cycles and must be planning on dose-dense chemotherapy with carboplatin and paclitaxel. They should not have received other recent cancer treatments, must show measurable disease, and have a good performance status (0 or 1). Women of childbearing potential need to use birth control and cannot be pregnant.

What is being tested?

The study tests the effectiveness of pembrolizumab combined with carboplatin and paclitaxel in treating certain cancers. Pembrolizumab is an immunotherapy drug that may boost the immune system's response against cancer cells. Carboplatin and paclitaxel are chemotherapy drugs aimed at stopping tumor growth by killing or preventing cell division.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from receiving the drugs intravenously, fatigue, blood disorders like low platelet counts or anemia, nerve damage which could cause numbness or tingling sensations (neuropathy), as well as increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a high-grade type that started in the ovary, peritoneum, or fallopian tube and is not mucinous.

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I've had 4 or fewer chemotherapy treatments for advanced ovarian, peritoneal, or fallopian tube cancer.

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

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I have little to no nerve damage from my treatment.

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I can provide a tissue sample from my tumor for testing.

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My kidney function is good, with a creatinine clearance rate of at least 60 mL/min.

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My liver function tests are within the required range.

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I have not received any treatment for ovarian cancer before.

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I am scheduled for a specific chemotherapy regimen using carboplatin and paclitaxel.

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I am set to have surgery to remove my tumor after 4 rounds of chemotherapy.

Exclusion Criteria

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

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I have been treated with specific immune system targeting drugs before.

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I have ovarian cancer and am not fit for certain diagnostic procedures before starting treatment.

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I have a lung condition not caused by an infection.

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I do not have severe illnesses like uncontrolled heart, lung, kidney diseases, high blood pressure, or active infections.

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I haven't had a monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.

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I am currently being treated for an infection.

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I have been diagnosed with HIV.

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I am currently receiving another type of biological therapy.

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My ovarian cancer is either mucinous or low grade.

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I have tuberculosis.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

To Evaluate Progression-free Survival of Paclitaxel/Carboplatin and Pembrolizumab in Patients With Advanced Stage, Metastatic Ovarian Cancer Undergoing NACT

Secondary study objectives

To Describe the Feasibility of Combination Therapy and Maintenance Pembrolizumab in This Population

To Evaluate the Safety of Combination and Maintenance Pembrolizumab

Other study objectives

Change in biomarker expression level

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (carboplatin, paclitaxel, and pembrolizumab)Experimental Treatment5 Interventions

NACT: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery. ADJUVANT THERAPY: Beginning 3-6 weeks after surgery, paclitaxel IV over 1 hour on days 1, 8, and 15, patients receive carboplatin IV over 1 hour on day 1, and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 20 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5450