RADVAX™ FOR RELAPSED/REFRACTORY HODGKIN LYMPHOMA: A PHASE II TRIAL OF NIVOLUMAB + LOW DOSE RADIOTHERAPY FOR INCOMPLETE RESPONDERS

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.