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Monoclonal Antibodies

pembrolizumab for Endometrial Cancer

Phase 2
Waitlist Available
Led By Haider Mahdi, MD
Research Sponsored by Haider Mahdi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have recurrent endometrial cancer or other solid tumors with deficient mismatch repair system. Mismatch repair deficiency is defined by 1. Immunohistochemistry with loss of expression of one of these proteins in tumor tissue as defined by standard of care: MLH1, MSH2, MSH6 and PMS2, 2. Microstaellite (MSI) unstable by PCR per standard of care, 3. MSI high by next generation sequencing using commercial platform specifically CARIS, TEMPUS or Foundation testing.
Must have had prior therapy with a PD1 inhibitor, pembrolizumab or other PD1/PDL1 inhibitor with confirmed radiographic progression of disease while on pembrolizumab or other PD1/PDL1 therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combination in women with endometrial cancer or other solid tumors.

Eligible Conditions
  • Recurrent Endometrial Cancer
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response
Secondary outcome measures
Adverse Events Related to Treatment
Clinical Benefit
Duration of Response (DOR)
+3 more

Side effects data

From 2022 Phase 3 trial • 1274 Patients • NCT02220894
12%
Weight decreased
9%
Diarrhoea
9%
Arthralgia
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Haemoptysis
9%
Nasopharyngitis
9%
Bronchitis
9%
Decreased appetite
9%
Hypothyroidism
9%
Constipation
6%
Pruritus
6%
Pneumonia
6%
Cough
6%
Anaemia
6%
Blood alkaline phosphatase increased
6%
Asthenia
6%
Headache
3%
Nausea
3%
Haematemesis
3%
Rash
3%
Pyrexia
3%
Chest pain
3%
Leukopenia
3%
Upper gastrointestinal haemorrhage
3%
Subdural haemorrhage
3%
Lymph gland infection
3%
White blood cell count decreased
3%
Pneumonia bacterial
3%
Tumour associated fever
3%
Dyspnoea
3%
Hyperthyroidism
3%
Myalgia
3%
Hyperglycaemia
3%
Hypertension
3%
Upper respiratory tract infection
3%
Back pain
3%
Malaise
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + SitravatinibExperimental Treatment2 Interventions
Standard of care pembrolizumab 200 mg IV combined with oral sitravatinib 100 mg oral QD every 21 days until disease progression, unacceptable toxicities or complete response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Sitravatinib
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Haider MahdiLead Sponsor
5 Previous Clinical Trials
193 Total Patients Enrolled
Mirati Therapeutics Inc.Industry Sponsor
69 Previous Clinical Trials
7,988 Total Patients Enrolled
Haider Mahdi, MDPrincipal InvestigatorUPMC Hillman Cancer Center
4 Previous Clinical Trials
134 Total Patients Enrolled

Frequently Asked Questions

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

What is the upper limit of participants taking part in this clinical experiment?

"Confirmative. According to the records published on clinicaltrials.gov, this investigation is currently looking for enrollees and was first posted September 8th 2022 with a subsequent edit occurring on September 12th 2022. A total of 30 participants are required from one medical centre."

Answered by AI

Has pembrolizumab earned recognition from the Food and Drug Administration?

"While pembrolizumab has been proven to be reasonably safe, its efficacy is yet to be confirmed. As such, this drug's safety was rated at 2 on a scale of 1-3."

Answered by AI

Is recruitment currently open for this experiment?

"Yes, clinicaltrials.gov details suggest this medical research is actively seeking participants for enrollment. It was initially posted on September 8th 2022 and last updated on the 12th of that month. 30 patients are required at one site for completion of the trial."

Answered by AI
~0 spots leftby Jul 2025