← Back to Search

PARP Inhibitor

Pembrolizumab + Olaparib for Endometrial Cancer

Phase 2
Recruiting
Led By Maria Rubinstein, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hormonal therapy for endometrial cancer discontinued at least one week prior to start of study therapy
Histologically confirmed persistent/recurrent endometrial carcinomas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test whether a combination of two drugs is an effective treatment for endometrial cancer or endometrial carcinosarcoma.

Who is the study for?
This trial is for adults with certain types of endometrial cancer who've had no more than three prior treatments (excluding hormonal therapy). They must have measurable disease, be in good physical condition, and not be pregnant or breastfeeding. People with severe allergies to the drugs being tested, active autoimmune diseases, recent immunosuppressive therapies, or uncontrolled illnesses cannot participate.Check my eligibility
What is being tested?
Researchers are testing a combination of two drugs—Pembrolizumab and Olaparib—to treat persistent or recurrent endometrial cancer. The study aims to determine the effectiveness and safety of this drug duo while monitoring for mild side effects in participants.See study design
What are the potential side effects?
Possible side effects include immune system reactions that can affect organs, fatigue, nausea, blood cell changes increasing infection risk. Specific reactions depend on individual health conditions and how they respond to Pembrolizumab and Olaparib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I stopped my hormonal therapy for endometrial cancer at least a week ago.
Select...
My endometrial cancer has come back or did not go away after treatment.
Select...
My endometrial cancer is either serous, carcinosarcoma, grade 3 endometrioid, or undifferentiated.
Select...
I am not pregnant, not breastfeeding, and follow birth control advice.
Select...
I am fully active or can carry out light work.
Select...
I finished chemotherapy more than 3 weeks ago.
Select...
My previous hormonal therapy does not count as a treatment.
Select...
I have had 1 to 3 treatments for endometrial cancer.
Select...
I am 18 years old or older.
Select...
I have another cancer that won't affect this treatment's safety or results.
Select...
I am HIV-positive, on treatment, and my viral load is undetectable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Overall response rate (ORR)
Secondary outcome measures
Frequency of AE's during therapy

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab with OlaparibExperimental Treatment2 Interventions
Eligible patients will receive olaparib in combination with pembrolizumab. Olaparib will be administered orally at 300 mg every 12 hours. Pembrolizumab will be administered intravenously (IV) at 200mg every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,931 Previous Clinical Trials
597,682 Total Patients Enrolled
2 Trials studying Endometrial Carcinosarcoma
104 Patients Enrolled for Endometrial Carcinosarcoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,974 Total Patients Enrolled
Maria Rubinstein, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05156268 — Phase 2
Endometrial Carcinosarcoma Research Study Groups: Pembrolizumab with Olaparib
Endometrial Carcinosarcoma Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT05156268 — Phase 2
Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156268 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots for participants in this trial?

"Verified. According to clinicaltrials.gov, this medical study has initiated recruitment and is searching for 25 participants at 7 locations. It was posted on January 27th 2022 and its last update occurred on October 21st 2022."

Answered by AI

What medical conditions have been found to be ameliorated by Pembrolizumab?

"Pembrolizumab is the go-to therapy for those with unresectable melanoma, as well as individuals facing a high risk of recurrence or microsatellite instability."

Answered by AI

How many sites are engaged in this research endeavor?

"At present, 7 medical centres are contributing to this study. These sites include Middletown, Basking Ridge and Montvale as well as 4 other locations. To minimize any travel requirements, it is recommended that participants select the closest site to them for enrollment."

Answered by AI

Is this a groundbreaking research endeavor?

"After AstraZeneca's initial research into pembrolizumab began in 2005, the drug was granted its Phase 1 approval. Nowadays, 1114 studies are underway for this medication at 3058 different locations and 66 countries."

Answered by AI

To what extent has Pembrolizumab been tested in other scientific experiments?

"Currently, 1114 clinical trials are researching the efficacy of Pembrolizumab with 143 studies at Phase 3. Out of all the locations conducting these experiments, Houston Texas is a major hub - though there are 42751 operating sites around the world."

Answered by AI

What is the enrollment capacity for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this trial is now open for enrollment and was initially published on January 27th 2022 with the most recent update occurring October 21st of that same year. 25 study participants are needed between 7 distinct medical centres."

Answered by AI

What potential adverse reactions might one experience while using Pembrolizumab?

"The safety of pembrolizumab is estimated to be a 2, taking into account the findings of this Phase 2 trial. Although data confirming its efficacy has yet to emerge, there are studies that support its relative safeness."

Answered by AI
~6 spots leftby Jan 2025