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

NCT03495713 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: UPCC 04418
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  Overall complete response rate as determined by re-staging scan

  25 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Subjects 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.

Drug: Nivolumab

Interventions

Nivolumab DRUG

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

Also known as: Opdivo

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19035, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: John P. Plastaras, MD, PhD
• Organization: Abramson Cancer Center at Penn Medicine

PennCancerTrials@emergingmed.com

855-216-0098

Study Officials

• John Plastaras, MD, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 12, 2018
• Study Start: November 2, 2018
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: January 17, 2024
• Results First Posted: June 28, 2023

Record last verified: 2023-12

Locations

US (1)