Loading clinical trials...

Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Stereotactic Body Radiation Therapy and Avelumab Immunotherapy for Treatment of Malignant Mesothelioma

An Efficacy and Safety Study of Avelumab Plus SBRT in Malignant Mesothelioma (MPM)

NCT03399552•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out whether the combination of avelumab and SBRT is safe and what effect avelumab has on mesothelioma when given in combination with SBRT. In addition, a goal of this protocol is to study the effect of radiation therapy on the immune system. It is thought that radiation treatment may create a form of 'vaccine' against cancer inside the body and immunotherapy may improve this effect. The combination of radiation treatment and immunotherapy may be more effective against cancer than either radiation or immunotherapy alone.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient willing and able to provide written informed consent for the trial.
•Patient age ≥ 18 at time of consent.
•Histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma (MPM).
•No plans for surgical resection.
•At least one prior line of systemic therapy. Note: Patients on prior immunotherapy are eligible.
•At least one targetable lesion appropriate for palliative SBRT and one non-target lesion
•Karnofsky Performance Score (KPS) ≥ 70%
•If of childbearing potential, must be willing to use highly effective mode of contraception for at least one month prior, during, and for 2 months after the end of active therapy
•Adequate organ function, defined as:
•* Absolute Neutrophil Count ≥ 1.5K/mcL.
+6 more criteria

Exclusion Criteria

•Currently participating and receiving another study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•Prior radiation therapy precluding SBRT
•Continuous oxygen use
•Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
•Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
•Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3)
•Prior Therapies:
•1. Treatment with a monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered (i.e., ≥ Grade 1 at baseline) from adverse events due to agents administered
•2. Prior chemotherapy, targeted small molecule therapy, within 4 weeks prior to study Day 1 or has not recovered (i.e., ≥ Grade 1 at baseline) from adverse events due to a previously administered agent (excluding Grade 2 neuropathy).
•3. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) within 4 weeks prior to study Day 1 or has not recovered (i.e., \>/= Grade 1 at baseline) from adverse events
+18 more criteria

Locations (7)

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Key Dates

Start Date

December 20, 2017

Primary Completion Date

January 20, 2023

Completion Date

January 20, 2023

Last Updated

October 23, 2023

Enrollment

ACTUAL participants

Conditions

Malignant Mesothelioma (MPM)

Interventions

Avelumab

DRUG

Stereotactic Body Radiation Therapy

RADIATION