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Monoclonal Antibodies
Avelumab + Talazoparib/Axitinib for Endometrial Cancer
Phase 2
Waitlist Available
Led By Panagiotis Konstantinopoulos, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age of 18 or greater years. Because insufficient dosing or adverse event data are currently available on the use of Avelumab, talazoparib, and/or axitinib in participants < 18 years of age, children are excluded from the study. Endometrial cancer is very rare in the pediatric population.
Additional inclusion criteria for the avelumab/axitinib cohort: Participants must have adequately controlled blood pressure and LVEF ≥ lower limit of normal (LLN) as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing Avelumab as a possible treatment for endometrial cancer that has come back or spread. It will be tested alone and with Talazoparib or Axitinib.
Who is the study for?
This trial is for women with recurrent or persistent endometrial cancer who haven't used PD-1/PD-L1 pathway drugs, PARP inhibitors (for certain cohorts), or axitinib. They must be adults with at least one prior chemotherapy regimen, not pregnant/breastfeeding, and have normal organ/marrow function. Participants need measurable disease by RECIST 1.1 standards and no severe illnesses that could interfere.Check my eligibility
What is being tested?
The study tests Avelumab alone and in combination with Talazoparib or Axitinib for treating endometrial cancer that has returned or hasn't responded to treatment. It aims to find out how well these treatments work on different genetic types of the cancer: MSS, MSI-H, and POLE-mutated.See study design
What are the potential side effects?
Possible side effects include immune-related reactions due to Avelumab (like inflammation in organs), blood pressure changes from Axitinib use, and bone marrow suppression which might lead to anemia or infections because of Talazoparib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My blood pressure is under control and my heart's pumping ability is normal.
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My endometrial cancer falls into either the MSI/POLE or MSS category.
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I have had at least one chemotherapy treatment for endometrial cancer.
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I am 18 years old or older.
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My endometrial cancer has a specific POLE mutation.
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I have a tumor or lymph node that meets the size requirements for measurement.
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I am fully active or can carry out light work.
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Side effects from my previous treatments are mild.
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I have never taken axitinib.
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My organs and bone marrow are functioning normally.
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I have never taken PARP inhibitor therapy.
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My endometrial cancer is MSI-H due to a lack of certain proteins.
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I have never taken PARP inhibitors before.
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I can provide a tissue sample from my cancer surgery or biopsy.
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I have never taken axitinib.
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I have not taken drugs targeting the PD-1/PD-L1 pathway.
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I have not taken drugs targeting the PD-1/PD-L1 pathway.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Activity Of Avelumab and Avelumab plus Talazoparib In Patients With Recurrent Or Persistent Endometrial Cancer
Clinical Activity of Avelumab plus Axitinib in Patients with MSS Recurrent or Persistent Endometrial Cancer
Secondary outcome measures
Clinical Activity of Combination Avelumab/Axitinib
Duration of Overall Survival
Duration of Progression Free Survival as Assessed by RECIST 1.1
+4 moreSide effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Infections and infestations
6%
General disorders and administration site conditions
6%
Investigations
6%
Gastrointestinal disorders
6%
Cardiac disorders
6%
Immune system disorders
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
Trial Design
4Treatment groups
Experimental Treatment
Group I: Pole Mutated Endometrial CancerExperimental Treatment1 Intervention
Participants with Pole mutated endometrial cancer Avelumab will be administered intravenously twice per cycle
Group II: MSS Endometrial CancerExperimental Treatment1 Intervention
Participants with MSS mutated endometrial cancer Avelumab will be administered intravenously twice per cycle
Group III: MSS Avelumab/Talazoparib Combination ArmExperimental Treatment2 Interventions
Participants with MSS mutated endometrial cancer Avelumab will be administered intravenously twice per cycle Talazoparib will be administered one time per day by mouth
Group IV: MSS Avelumab/Axitinib Combination ArmExperimental Treatment2 Interventions
Participants with MSS mutated endometrial cancer Avelumab will be administered intravenously twice per cycle Axitinib will be administered twice per day by mouth
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Talazoparib
2021
Completed Phase 2
~2770
Axitinib
2020
Completed Phase 2
~3050
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,766 Total Patients Enrolled
8 Trials studying Endometrial Cancer
1,430 Patients Enrolled for Endometrial Cancer
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,767 Total Patients Enrolled
3 Trials studying Endometrial Cancer
248 Patients Enrolled for Endometrial Cancer
Panagiotis Konstantinopoulos, MD, PhDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
1 Previous Clinical Trials
5 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.I am 18 years old or older.You have an autoimmune disease that may get worse if you take a medication that boosts your immune system.I have had at least one chemotherapy treatment for endometrial cancer.I am 18 years old or older.I have not taken immunosuppressive drugs in the last 7 days.My blood pressure is under control and my heart's pumping ability is normal.You cannot be taking any other experimental drugs.You have had an allergic reaction to avelumab or any similar medication before.My endometrial cancer falls into either the MSI/POLE or MSS category.I have had at least one chemotherapy treatment for endometrial cancer.I have had hormone therapy before.I have an active heart condition.I have not received any vaccines within 4 weeks before starting avelumab, and I won't get any while on the trial except for inactivated vaccines.You will not be eligible if you have protein in your urine, blood in your stool, active gastrointestinal bleeding, or serious heart problems. You cannot take certain medications that affect blood clotting, and you cannot take drugs that interact with the study medication.My endometrial cancer has a specific POLE mutation.I have a tumor or lymph node that meets the size requirements for measurement.I have an illness related to HIV or AIDS.I have had hormone therapy before.I am fully active or can carry out light work.I have brain metastases.I have been treated with drugs targeting the immune system for cancer.I am currently on medication for an infection.I have not had any other type of cancer, except under certain conditions.I do not use herbal products or folk remedies.I can provide a tissue sample from my cancer surgery or biopsy.You have had an organ transplant or stem-cell transplant in the past.Side effects from my previous treatments are mild.I do not have any uncontrolled illnesses.I have never taken axitinib.I am on low-dose steroids for hormone replacement, not exceeding 10 mg of prednisone daily.My organs and bone marrow are functioning normally.You have a history of alcohol or drug abuse.I have never taken PARP inhibitor therapy.My endometrial cancer is MSI-H due to a lack of certain proteins.I do not have any other major health issues.I have never taken PARP inhibitors before.I have severe stomach or intestinal problems.You have experienced serious allergic reactions to monoclonal antibodies, have a history of anaphylaxis, or have uncontrolled asthma.My endometrial cancer is not caused by certain genetic changes.I have never taken axitinib.I have not taken drugs targeting the PD-1/PD-L1 pathway.I have not taken drugs targeting the PD-1/PD-L1 pathway.
Research Study Groups:
This trial has the following groups:- Group 1: Pole Mutated Endometrial Cancer
- Group 2: MSS Endometrial Cancer
- Group 3: MSS Avelumab/Talazoparib Combination Arm
- Group 4: MSS Avelumab/Axitinib Combination Arm
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 is the current size of this experiment's cohort?
"Correct. According to the information on clinicaltrials.gov, this medical study was initially shared on November 14th 2016 and is actively recruiting participants as of June 27th 2022. The trial requires 105 patients from 4 different sites."
Answered by AI
Has Avelumab attained regulatory acceptance from the FDA?
"Prior data indicates that Avelumab is safe and thus earned a score of 2. This medication has reached phase two trials, yet efficacy remains untested."
Answered by AI
What particular medical conditions may Avelumab be deployed to manage?
"Patients with brca1 gene mutations, Merkel cell carcinoma, and malignant neoplasms may all benefit from Avelumab therapy."
Answered by AI
Is enrollment for this study still open?
"Affirmative. Information on clinicaltrials.gov attests that this research endeavour, which was first advertised on November 14th 2016, is presently recruiting participants. Approximately 105 human subjects need to be enrolled from 4 distinct medical centres."
Answered by AI
Are there any further investigations that have utilized Avelumab?
"Initially tested at City of Hope in 2010, avelumab has since been the subject of 145 completed clinical trials. Currently, there are 195 active studies based out of Chicago, Illinois."
Answered by AI
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