← Back to Search

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
No Placebo-Only Group

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 below
Select...
My cancer is a high-grade type that started in the ovary, peritoneum, or fallopian tube and is not mucinous.
Select...
I've had 4 or fewer chemotherapy treatments for advanced ovarian, peritoneal, or fallopian tube cancer.
Select...
I have not received any treatment for ovarian cancer before.
Select...
I am set to have surgery to remove my tumor after 4 rounds of chemotherapy.
Select...
I am scheduled for a specific chemotherapy regimen using carboplatin and paclitaxel.
Select...
I have little to no nerve damage from my treatment.
Select...
I can provide a tissue sample from my tumor for testing.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My kidney function is good, with a creatinine clearance rate of at least 60 mL/min.
Select...
My liver function tests are within the required range.
Select...
My blood clotting time is normal or managed if I'm on blood thinners.
Select...
My blood clotting time is normal or near normal, even if I'm on blood thinners.
Select...
I am a woman who can have children and have a recent negative pregnancy test.
Select...
I am using two birth control methods or am not having sex to avoid pregnancy during the study.
Select...
I have fresh frozen tissue available for research from a recent biopsy.

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

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
Paclitaxel
2011
Completed Phase 4
~5380
Pembrolizumab
2017
Completed Phase 3
~2050
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,943 Previous Clinical Trials
1,775,347 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

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
~2 spots leftby Jul 2024