Effect of Radiotherapy and Nivolumab in Relapsed classical Hodgkin Lymphoma

Phase 1

• Conditions: Improvement of efficacy of nivolumab in patients with relapsed or refractory classical Hodgkin Lymphoma who recently progressed on anti-PD1 therapy.; MedDRA version: 20.0Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's diseaseSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003334-82-NL
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-07
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

- Relapsed/refractory cHL with progression while treated with an anti-PD1 antibody or
Relapsed/refractory cHL with stable disease for > 6 months as best response to ongoing anti-PD1 antibody therapy
- At least two distinct FDG-avid HL-lesions with at least 5cm distance between them, and one of them considered eligible for irradiation with 20Gy
- One but the irradiated lesion has to be outside the 10% isodose in RT planning confirmed by the Central Response Evaluation Panel (CREP)
- Age >18 years, all sexes
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Nodular lymphocyte-predominant HL or grey-zone lymphoma
- Evidence of active, non-infectious lung disorder with DLCOc <50%
- History of long-term or ongoing ingestion of immunosuppressive agents >10mg prednisone/d
- Any other serious disease or organ dysfunction which might impair protocol treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to show efficacy of the experimental treatment strategy. ;Secondary Objective: Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.;Primary end point(s): Abscopal response rate (ARR-6) with abscopal response centrally confirmed as restaging result after RT to a single lesion and at least four but not more than six nivolumab infusions (RE-6 result);Timepoint(s) of evaluation of this end point: The first interim analysis of the abscopal response rate (ARR-6) will be performed as soon as the primary endpoint assessment has been documented for 9 evaluable stage I patients.<br>If no abscopal response have been seen in these patients, the trial will be terminated.<br>Otherwise a final analysis will be done when additional 20 patients have been evaluated after treatment and the first restaging in stage-2 of the trial.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall abscopal response rate (OARR) <br>Overall response rate (ORR) <br>Duration of response (DOR)<br>Progression-free survival (PFS) <br>Overall survival (OS)<br>Adverse events (AE)<br>Feasibility aspects <br>Quality of life (QoL) and life situation (LS) aspects<br>Correlative studies;Timepoint(s) of evaluation of this end point: At each visit and the final analysis will be done at the end of the study.