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Antibody-Drug Conjugate

IMGN853 + Pembrolizumab for Endometrial Cancer

Phase 2
Waitlist Available
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
Must not have
Participants with prior exposure to IO agents targeting the PD-1/PD-L1 pathway who discontinued therapy due to treatment-related toxicity deemed to be specifically related to IO therapy
Required use of folate-containing supplements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I stopped IO therapy due to side effects directly related to the treatment.
Select...
I am taking folate supplements.
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I currently have a serious infection.
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I have had or currently have lung inflammation treated with steroids.
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I haven't had a serious illness in the last 6 months.
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I have an ongoing eye condition affecting my cornea.
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I have active brain metastases or cancer in the lining of my brain.
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I have an autoimmune disease that could worsen with immune-stimulating treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Systemic infection
1%
Clostridium difficile colitis
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

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: 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 3
~3150

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,110 Previous Clinical Trials
358,280 Total Patients Enrolled
9 Trials studying Endometrial Cancer
2,166 Patients Enrolled for Endometrial Cancer
ImmunoGen, Inc.Industry Sponsor
32 Previous Clinical Trials
4,003 Total Patients Enrolled
3 Trials studying Endometrial Cancer
473 Patients Enrolled for Endometrial Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,785 Total Patients Enrolled
21 Trials studying Endometrial Cancer
4,847 Patients Enrolled for Endometrial Cancer
Rebecca Porter, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

IMGN853 (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT03835819 — Phase 2
Endometrial Cancer Research Study Groups: IMGN853 + Pembrolizumab
Endometrial Cancer Clinical Trial 2023: IMGN853 Highlights & Side Effects. Trial Name: NCT03835819 — Phase 2
IMGN853 (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03835819 — Phase 2
~3 spots leftby Dec 2025
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