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Antibody-Drug Conjugate
IMGN853 + Pembrolizumab for Endometrial Cancer
Phase 2
Recruiting
Led By Rebecca Porter, 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
Participants must have normal organ and marrow function as defined: leukocytes ≥3,000/mcL, absolute neutrophil count ≥1,500/mcL, platelets ≥100,000/mcL, hemoglobin ≥ 9.0 g/dL, total bilirubin ≤ 1.5 x institutional upper limit of normal, AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, creatinine ≤ institutional upper limit of normal OR creatinine clearance ≥40 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
Patients must have had one, but no more than three lines of chemotherapy for endometrial carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying the side effects of the drug combination and how well it works in treating endometrial cancer.
Who is the study for?
This trial is for adults with advanced or recurrent serous endometrial cancer that's microsatellite stable and FRα positive. Participants must have had 1-3 prior chemotherapy treatments but not certain other drugs, and should be in good health with no serious infections or autoimmune diseases. Women must use birth control and can't be pregnant.Check my eligibility
What is being tested?
The study tests a combination of two drugs, mirvetuximab soravtansine (IMGN853) and pembrolizumab, as a treatment for endometrial cancer. It aims to see how well these drugs work together in patients who meet specific criteria.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system due to pembrolizumab, such as inflammation of organs, infusion reactions from IMGN853 which may affect the eyes or liver function changes. Each patient's experience with side effects may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show normal organ function and I don't have anemia.
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I have had 1 to 3 chemotherapy treatments for endometrial cancer.
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My cancer can be measured by scans, even in areas previously treated with radiation.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I have never been treated with drugs targeting the folate receptor.
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My tumor is microsatellite stable based on specific gene tests.
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
Objective Response Rate
Progression Free Survival
Secondary outcome measures
Duration of response
Immune-related progression of disease
Immune-related progression-free survival
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: IMGN853 + PembrolizumabExperimental Treatment2 Interventions
Pembrolizumab is administered intravenously once every 3 weeks
IMGN853 is administered intravenously once every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,945 Total Patients Enrolled
8 Trials studying Endometrial Cancer
1,471 Patients Enrolled for Endometrial Cancer
ImmunoGen, Inc.Industry Sponsor
32 Previous Clinical Trials
3,796 Total Patients Enrolled
3 Trials studying Endometrial Cancer
277 Patients Enrolled for Endometrial Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,111 Total Patients Enrolled
19 Trials studying Endometrial Cancer
4,108 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a type of advanced or recurrent serous endometrial cancer.I have had 1 to 3 chemotherapy treatments for endometrial cancer.My cancer can be measured by scans, even in areas previously treated with radiation.My blood tests show normal organ function and I don't have anemia.I finished my last cancer treatment at least 4 weeks ago, or 2 weeks for focal radiation.My tumor is FRα positive, confirmed by a specific test.I am 18 years old or older.My doctor considers any other cancer I've had as cured.I haven't taken immunosuppressive drugs in the last week, with some exceptions.I am fully active or can carry out light work.I have had hormonal therapy for my condition, but it doesn't count as a prior treatment line.I haven't had chemotherapy in the last 4 weeks or radiotherapy in the last 2 weeks.I stopped IO therapy due to side effects directly related to the treatment.I am taking folate supplements.I currently have a serious infection.I have not received a live vaccine in the last 30 days.I have had or currently have lung inflammation treated with steroids.I haven't had a serious illness in the last 6 months.I have an ongoing eye condition affecting my cornea.I have never been treated with drugs targeting the folate receptor.I have had immunotherapy targeting PD-1/PD-L1 before.I have active brain metastases or cancer in the lining of my brain.My tumor is microsatellite stable based on specific gene tests.I have an autoimmune disease that could worsen with immune-stimulating treatments.
Research Study Groups:
This trial has the following groups:- Group 1: IMGN853 + 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.
Could you elaborate on what other investigations have been conducted regarding Pembrolizumab?
"Currently, a total of 968 trials involving pembrolizumab are in progress. Of these studies, 123 have advanced to Phase 3. Houston, Texas is the hub for many of these experiments but there exist over 36 thousand sites conducting research on this medication."
Answered by AI
Is Pembrolizumab usage associated with any adverse effects?
"The safety of Pembrolizumab was assessed as a 2 due to the Phase 2 status, indicating there is evidence that it's safe but no data yet showing efficacy."
Answered by AI
In which medical scenarios is Pembrolizumab most effectively employed?
"Pembrolizumab is employed to manage a range of malignant neoplasms, including unresectable melanoma, microsatellite instability high tumours, and cases where chemotherapy has not been successful."
Answered by AI
To what extent is this experiment being conducted with participants?
"Affirmative. According to the details on clinicaltrials.gov, this research project was brought into effect on January 2nd 2020 and has been updated most recently on October 24th 2022. 35 individuals are being accepted at 3 different sites for participation in the study."
Answered by AI
Does this experiment currently have room for additional participants?
"According to the most recent records on clinicaltrials.gov, this medical trial is actively recruiting participants. It was first posted in February of 2020 and underwent its latest update at the end of October 2022."
Answered by AI
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