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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

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival
Response rate
Secondary outcome measures
Incidence of adverse events
Overall survival
Proportion of patients able to complete all planned cycles of therapy
Other outcome measures
Change in biomarker expression level

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
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,248 Total Patients Enrolled
47 Trials studying Ovarian Cancer
16,745 Patients Enrolled for Ovarian Cancer
Amir Jazaeri, MDPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
121 Total Patients Enrolled
3 Trials studying Ovarian Cancer
121 Patients Enrolled for Ovarian Cancer

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02520154 — Phase 2
Ovarian Cancer Research Study Groups: Treatment (carboplatin, paclitaxel, and pembrolizumab)
Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02520154 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02520154 — Phase 2
~0 spots leftby Jul 2024