Lymphoma RadVax LYMPHOMA: A PHASE II TRIAL OF NIVOLUMAB + LOW DOSE RADIOTHERAPY FOR INCOMPLETE RESPONDERS

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II single-arm, single-site, open label clinical trial with r/r HL patients, aimed to determine whether a RadVax approach using low-dose RT added to nivolumab can improve response among patients who do not achieve a CR to nivolumab alone. The long-term goal is to develop an effective regimen for r/r HL patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Antibodies, Monoclonal; Nivolumab

Criteria

Inclusion Criteria:

• Pathologically confirmed Hodgkin lymphoma for whom nivolumab is clinically indicated.

• Relapsed/refractory disease.

• ≥2 sites of measurable disease, at least one outside of intended RT fields.

• Age ≥ 18 years.

• ECOG performance status of 0-2.

• Standard laboratory criteria for hematologic, and biochemical, and urinary indices within a range that, in the opinion of the physician, clinically supports enrollment of the subject on the trial.

• Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial.

• Ability to provide written informed consent.

Exclusion Criteria:

• Subjects with contraindications to immune checkpoint therapy, as follows:

• Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.

• Prior organ allograft or allogeneic bone marrow transplantation.

• Subjects with contraindications to immune checkpoint therapy, as follows:

• Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity.

• Prior organ allograft or allogeneic bone marrow transplantation.

• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.

• Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the principal investigator.

• Condition requiring systemic treatment with either corticosteroids.

• Systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted. Steroids as anti-emetics for chemotherapy are strongly discouraged

• Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted.

• Pregnant women, women planning to become pregnant and women that are nursing.