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-AT
• Lead Sponsor: niversity of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-05
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

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 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

-Nodular-lymphocyte predominant HL (NLPHL) or composite/greyzone lymphoma
-Lymphoma involving the central nervous system
-Naïve to treatment with anti-PD1 targeting antibodies
-Prior allogeneic stem-cell transplantation (alloSCT), if one or more of the following conditions are met:
a. AlloSCT conducted <12 months prior to registration for the screening phase
b. Requiring continued immunosuppression beyond 7d) at registration for the screening phase
c. History of acute graft-versus-host disease =°3
d. History of chronic graft-versus-host disease =°3

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: please refer to E.5.1

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: please refer to E.5.1