Pembrolizumab for Mismatch Repair Deficiency

M D Anderson Cancer Center, Houston, TX
Mismatch Repair Deficiency+6 More ConditionsPembrolizumab - Biological
Eligibility
18+
All Sexes

Study Summary

This trial is studying how well pembrolizumab works before surgery in treating patients with MSI-H or dMMR solid cancers.

Eligible Conditions
  • Mismatch Repair Protein Deficiency
  • Loss of PMS2 Expression
  • Loss of MSH2 Expression
  • High Frequency Microsatellite Instability
  • Microsatellite Instability-High (MSI-H)
  • Locally Advanced Malignant Solid Tumor
  • Lynch Syndrome

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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1
Pembrolizumab
1
Pembrolizumab
1
Pembrolizumab

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 2 years

1 year
Pathological complete response (pCR)
At 1 year
Pathological complete response
Rate of organ sparing
Year 2
Relapse-free survival
Year 2
Overall survival
Up to 2 years
Incidence of adverse events
Tumor response

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
Pembrolizumab
2
Pembrolizumab
2
Pembrolizumab

Side Effects for

Pembrolizumab+EP
54%Neutropenia
45%Anaemia
38%Nausea
34%Alopecia
31%Decreased appetite
29%Constipation
27%Fatigue
26%Thrombocytopenia
22%Leukopenia
21%Diarrhoea
20%Cough
17%Dyspnoea
17%Asthenia
16%Vomiting
14%Dizziness
14%Pyrexia
13%Arthralgia
13%Rash
13%Headache
12%Hypothyroidism
11%Pruritus
11%Insomnia
11%Back pain
10%Weight decreased
9%Hyponatraemia
9%Aspartate aminotransferase increased
8%Oedema peripheral
8%Upper respiratory tract infection
8%Alanine aminotransferase increased
8%Pneumonia
7%Hypokalaemia
7%Blood creatinine increased
7%Abdominal pain
7%Febrile neutropenia
6%Abdominal pain upper
6%Stomatitis
6%Dysgeusia
6%Erythema
6%Dry skin
5%Dyspepsia
5%Dysphagia
5%Blood alkaline phosphatase increased
5%Chest pain
5%Musculoskeletal pain
5%Hyperthyroidism
5%Hypertension
5%Nasopharyngitis
5%Musculoskeletal chest pain
5%Pain in extremity
4%Hypotension
4%Urinary tract infection
2%Death
2%Pulmonary embolism
2%Acute kidney injury
2%Pneumonitis
2%Atrial fibrillation
1%Hemiparesis
1%Inappropriate antidiuretic hormone secretion
1%Superior vena cava syndrome
1%Neutropenic sepsis
1%Transient ischaemic attack
1%Diabetes mellitus
1%Pneumothorax
1%Gastritis
1%Aortic aneurysm
1%Sepsis
1%Pleural infection
1%Infusion related reaction
1%Clostridium difficile colitis
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab+EP ARM group. Side effects include: Neutropenia with 54%, Anaemia with 45%, Nausea with 38%, Alopecia with 34%, Decreased appetite with 31%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Treatment (pembrolizumab)
1 of 1

Experimental Treatment

35 Total Participants · 1 Treatment Group

Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2

Treatment (pembrolizumab)
Biological
Experimental Group · 1 Intervention: Pembrolizumab · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,281 Previous Clinical Trials
41,235,091 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,849 Previous Clinical Trials
1,793,489 Total Patients Enrolled
Michael J OvermanPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
283 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have cancer that has spread to nearby tissues or organs and cannot be completely removed by surgery or can be removed but has a high probability of coming back.
References

Frequently Asked Questions

How many participants are actively engaged in this clinical experiment?

"Affirmative. Clinicaltrials.gov data shows that the recruitment for this medical trial, which was opened on September 17th 2019, is still open and actively seeking participants. 35 patients need to be enrolled from a single location." - Anonymous Online Contributor

Unverified Answer

Has the regulatory agency given authorization for Pembrolizumab?

"Data has only been collected on Pembrolizumab's safety, so we have assigned it a score of 2." - Anonymous Online Contributor

Unverified Answer

Have there been other investigations utilizing Pembrolizumab?

"Currently, Pembrolizumab has 961 active clinical trials running worldwide, 122 of which are in the third stage. Houston is a major hub for this medication research with around 35 thousand locations conducting tests on it." - Anonymous Online Contributor

Unverified Answer

What are the overarching aims of this medical study?

"The primary objective of this research, evaluated over a 12 month period, is to assess the pathological complete response (pCR) rate. Secondary objectives include tracking adverse events using Common Terminology Criteria for Adverse Events toxicity and post-operative complications classified with Clavien-Dindo's framework; additionally, organ sparing rates amongst those receiving at least 3 doses of neoadjuvant pembrolizumab will be considered. Finally, relapse-free survival data determined by Kaplan and Meier's methodology shall also be obtained." - Anonymous Online Contributor

Unverified Answer

For what conditions is Pembrolizumab typically prescribed?

"Pembrolizumab is regularly administered to patients suffering from malignant neoplasms, and can also be beneficial in treating microsatellite instability high, unresectable melanoma, and cancer that has progressed following chemotherapy." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities to partake in this investigation?

"This medical trial is currently recruiting participants, as noted on the clinicaltrials.gov website. It was initially listed on September 17th 2019 and has most recently been amended in March 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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