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Checkpoint Inhibitor

Pembrolizumab + Cryoablation for Mesothelioma

Phase 1
Waitlist Available
Led By Michael Offin, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 12 weeks of cryoablation
Awards & highlights

Study Summary

This trial is testing whether a combination of two cancer treatments is safe and effective for people with mesothelioma.

Who is the study for?
This trial is for adults with mesothelioma who've had at least one previous systemic therapy but not pembrolizumab as the most recent treatment. They must have a Karnofsky Performance Score of 70% or higher, adequate organ function, and agree to use effective contraception. Exclusions include those on continuous oxygen, certain medications like high-dose steroids, active infections like HIV/HBV/HCV, other progressing cancers, or severe allergies to pembrolizumab.Check my eligibility
What is being tested?
The study tests if combining pembrolizumab (an immunotherapy drug) with cryoablation (a procedure that freezes cancer cells) is safe and works against mesothelioma. Participants will receive both treatments and be monitored for side effects and effectiveness in fighting their cancer.See study design
What are the potential side effects?
Possible side effects from pembrolizumab include immune reactions affecting organs, fatigue, skin issues, flu-like symptoms and potential infusion-related reactions. Cryoablation may cause pain at the site of treatment, bleeding or damage to nearby tissue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 12 weeks of cryoablation
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 12 weeks of cryoablation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
number of patients with an adverse event (AE) defined as any grade 3 or higher non-hematologic toxicity

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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: pembrolizumab followed by cryoablationExperimental Treatment2 Interventions
The treatment will consist of 1 cycle of pembrolizumab (200mg/flat dose) intravenously followed by cryoablation of an ablation index lesion 1-7 days prior to the start of cycle 2. Pembrolizumab will be continued for up to 24 months, until disease progression, or intolerable toxicity. Treatment beyond progression at discretion of the treating physician and Study PI. There will be a research biopsy within 1 week of cycle 5 start and an optional biopsy at end of treatment and/or progression of disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Image-guided cryoablation
2021
Completed Phase 1
~10
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,890 Total Patients Enrolled
19 Trials studying Mesothelioma
795 Patients Enrolled for Mesothelioma
Michael Offin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
22 Total Patients Enrolled
1 Trials studying Mesothelioma
22 Patients Enrolled for Mesothelioma

Media Library

Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05071014 — Phase 1
~1 spots leftby Jun 2025
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