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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03495713
Other study ID # UPCC 04418
Secondary ID
Status Recruiting
Phase Phase 2
First received April 5, 2018
Last updated April 5, 2018
Start date March 2, 2018
Est. completion date December 1, 2020

Study information

Verified date April 2018
Source Abramson Cancer Center of the University of Pennsylvania
Contact John Plastaras, MD, PhD
Phone 855-216-0098
Email PennCancerTrials@emergingmed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 1, 2020
Est. primary completion date March 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nivolumab
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

Locations

Country Name City State
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Events 2 years
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