Lymphoma RadVax LYMPHOMA: A PHASE II TRIAL OF NIVOLUMAB + LOW DOSE RADIOTHERAPY FOR INCOMPLETE RESPONDERS
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Nivolumab
Intervention description: Nivolumab 3 mg/kg will be administered on day 1 (pre-response assessment week 0) and on day 1 and continued per standard of care and institutional practices. A
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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.