Clinical Trials /

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

NCT03495713

Description:

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.

Related Conditions:
  • Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Lymphoma RadVax LYMPHOMA: A PHASE II TRIAL OF NIVOLUMAB + LOW DOSE RADIOTHERAPY FOR INCOMPLETE RESPONDERS
  • Official Title: RadVax for Relapsed/Refractory Hodgkin's Lymphoma: A Phase II Trial of Nivolumab + Low Dose Radiotherapy for Incomplete Responders

Clinical Trial IDs

  • ORG STUDY ID: UPCC 04418
  • NCT ID: NCT03495713

Conditions

  • Hodgkin Lymphoma

Interventions

DrugSynonymsArms
NivolumabOpdivoSingle Arm

Purpose

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.

Detailed 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. At the week 1 biomarker
      collection, research FDG PET/CT will be performed to assess for FDG "flare." At week 8-12,
      PET/CT will be performed for the first response assessment. If a complete anatomic response
      is seen, nivolumab monotherapy will be continued on day 1 and continued per standard of care
      and institutional practices.

      By contrast, if at week 8 less than a complete anatomic response is seen, radiotherapy to 4
      Gy x 2 fractions will be administered (post-response assessment week 0). The patient will be
      evaluated by a radiation oncologist while on treatment, and toxicities will be recorded.
      Nivolumab will be continued on day 1 and continued per standard of care and institutional
      practices.

      In either scenario, a second response assessment will be conducted ~8-12 weeks after the
      first response assessment. In either scenario, nivolumab monotherapy will be continued at the
      discretion of the treating medical oncologist.

      If there is less than CR post-RT and there is an additional untreated non-target lesion that
      can be followed, radiotherapy can again be administered when disease progresses to a
      previously untreated lesion, after which the patient will continue on the post-RT follow-up
      algorithm.
    

Trial Arms

NameTypeDescriptionInterventions
Single ArmExperimentalSubjects will receive initial treatment with the immunomodulatory agent, nivolumab, followed by low-dose (4 Gy x 2) involved-site radiotherapy in subjects with less than an anatomic CR after the first restaging scan. Patients with anatomic CR will continue nivolumab alone without radiotherapy. Eligible patients will have r/r disease with at least 2 sites of measurable disease, and must be eligible for treatment with nivolumab.
  • Nivolumab

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete response rate
Time Frame:25 weeks
Safety Issue:
Description:Overall complete response rate as determined by re-staging scan

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

Last Updated

October 29, 2019