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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,206 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had cancer before, but it was either treated over 5 years ago, was a non-threatening skin cancer, or was early-stage endometrial cancer.I have not received a live vaccine in the last 30 days.My brain metastases are stable, and I haven't used steroids in the last 7 days.I have been treated with specific immune system targeting drugs before.I have ovarian cancer and am not fit for certain diagnostic procedures before starting treatment.Your platelet count is at least 100,000 per microliter.You have had allergic reactions to drugs similar to carboplatin or paclitaxel that did not improve with standard treatment.My cancer is a high-grade type that started in the ovary, peritoneum, or fallopian tube and is not mucinous.I've had 4 or fewer chemotherapy treatments for advanced ovarian, peritoneal, or fallopian tube cancer.I am fully active or restricted in physically strenuous activity but can do light work.You have a tumor that can be measured using specific guidelines for evaluating tumor response.Your hemoglobin level is at least 9 g/dL or 5.6 mmol/L.I have little to no nerve damage from my treatment.You have a current infection with hepatitis B or C.I have a lung condition not caused by an infection.My blood clotting time is normal or near normal, even if I'm on blood thinners.I am using two birth control methods or am not having sex to avoid pregnancy during the study.I have fresh frozen tissue available for research from a recent biopsy.I am a woman who can have children and have a recent negative pregnancy test.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am currently being treated for an infection.I have been diagnosed with HIV.I am currently receiving another type of biological therapy.My kidney function is good, with a creatinine clearance rate of at least 60 mL/min.My liver function tests are within the required range.I haven't had a monoclonal antibody treatment in the last 4 weeks or have recovered from its side effects.I do not have severe illnesses like uncontrolled heart, lung, kidney diseases, high blood pressure, or active infections.I haven't had cancer treatment in the last 2 weeks and have recovered from any side effects, except for mild neuropathy.I can provide a tissue sample from my tumor for testing.I have not received any treatment for ovarian cancer before.My ovarian cancer is either mucinous or low grade.I have tuberculosis.I am scheduled for a specific chemotherapy regimen using carboplatin and paclitaxel.Your bilirubin levels must be within a certain range, or you may not be able to participate.My blood clotting time is normal or managed if I'm on blood thinners.You have a sufficient number of a type of white blood cell called neutrophils.I am set to have surgery to remove my tumor after 4 rounds of chemotherapy.You are allergic to pembrolizumab or any of the ingredients in it.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (carboplatin, paclitaxel, and pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What prior research exists into the use of Paclitaxel?
"Presently, 1988 clinical trials centered around Paclitaxel are ongoing. 413 of those investigations have reached Phase 3 and 91452 different medical centres are participating in these experiments. Notably, the majority of studies conducted with Paclitaxel take place in Shanghai."
Answered by AI
In what geographic areas is this investigation being held?
"This clinical trial encompasses 5 medical centres, with the two MD Anderson locations in The Woodlands and Sugar Land being most prominent. Additionally, there are additional sites located in Nassau Bay as well as 3 other unspecified areas."
Answered by AI
Has the FDA sanctioned Paclitaxel for consumer usage?
"Our team of experts at Power put Paclitaxel's safety rating on a scale from 1 to 3, and it received a score of 2. This is because this Phase 2 trial does not have any data backing its efficacy yet, but there are some results attesting to its safety."
Answered by AI
What diseases does Paclitaxel typically address?
"Paclitaxel is a common chemotherapy choice for handling malignant neoplasms, but it may also be beneficial to patients with unresectable melanoma and microsatellite instability high or those at elevated risk of recurrence."
Answered by AI
How many participants are being enrolled in this research study?
"This trial is no longer enrolling participants. Initially listed on July 5th, 2016 and last modified October 20th 2022, it has since concluded its recruitment. For those considering other studies related to malignant neoplasm of ovary or Paclitaxel there are 621 and 1988 respective trials currently searching for volunteers."
Answered by AI
Are researchers currently enrolling participants for this investigation?
"This clinical trial has concluded recruitment, having first been posted on July 5th 2016 and last updated October 20th 2022. There are currently 621 studies open for enrollment regarding malignant neoplasm of ovary and 1988 trials recruiting patients to receive Paclitaxel treatment."
Answered by AI
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