A Study of Pembrolizumab and Radiation Therapy in People With Mesothelioma

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04897022
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Malignant Pleural Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Fixed dose of pembrolizumab 200mg IV q3 weeks
  • IMPRINT — RADIATION
    The starting radiation dose will consist of 400cGy x5 fractions. Doses will be escalated by 100cGy per fraction (i.e. 400cGy, 500cGy, 600cGy) for a total of 3 dose levels. The MTD will be evaluated using a modified Continuous Reassessment Method. Dose limiting toxicities (DLTs) are defined as any treatment-related non-hematologic toxicity with a CTCAE v5 Grade ≥3 or grade ≥2 pneumonitis that requires use of steroids occurring after the start of IMPRINT through the first 3 months after the last fraction.

Study Details

The purpose of this study is to find out whether IMPRINT in combination with pembrolizumab is a safe treatment for people with malignant pleural mesothelioma (MPM).The highest dose of IMPRINT that causes few or mild side effects when given in combination with pembrolizumab will be found. Once the highest safe dose of IMPRINT is found, it will be tested in combination with pembrolizumab in future participants to see whether the combination may be an effective treatment for MPM.

Key Dates

First listed
May 21, 2021
Start date
Aug 10, 2021
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with malignant pleural mesothelioma (MPM)
    Participants will be diagnosed with malignant pleural mesothelioma and be deemed unresectable per thoracic surgeon assessment

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of IMPRINT [ Time Frame: 6 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748-
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645-
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)CommackNew York11725-
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering Nassau (Limited protocol activities)Rockville CentreNew York11553-

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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