Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma

NCT04373083 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: R2810-ONC-16152017-004265-28
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL). Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.

Conditions

Hodgkin Lymphoma

Keywords

Early Stage; Favorable; Classical; classical Hodgkin lymphoma (cHL)

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) at 1 year

  From randomization up to 1 year

Secondary Outcomes (9)

• PFS at 2 and 3 years

  From randomization up to 3 years

• Overall survival (OS) at 1, 2, and 3 years

  From randomization up to 3 years

• Incidence of acute toxicities

  Up to 90 days after study treatment

• Rate of patients with long-term fatigue using EORTC-QLQ-FA12

  12-18 months after randomization

• Rate of patients with long-term fatigue using EORTC-QLQ-C30

  12-18 months after randomization

Study Arms (2)

Concomitant treatment

EXPERIMENTAL

Treatment Group A

Drug: Cemiplimab; Radiation: Involved-site radiotherapy (IS-RT)

Sequential treatment

EXPERIMENTAL

Treatment Group B

Drug: Cemiplimab; Radiation: Involved-site radiotherapy (IS-RT)

Interventions

Cemiplimab DRUG

Administered in 3-week intervals

Also known as: REGN2810, Libtayo

Concomitant treatment; Sequential treatment

Involved-site radiotherapy (IS-RT) RADIATION

Patients will receive IS-RT with a dose of 20 Gy. Involved-site radiotherapy will be carried out on the basis of 3D imaging as described in the protocol

Concomitant treatment; Sequential treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven classical HL
• First diagnosis, no previous treatment
• Stage I-II without risk factors as defined in the protocol

You may not qualify if:

• Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)
• Prior malignancy within the previous 5 years (except for locally treatable cancers that have been apparently cured by complete resection)
• Prior chemotherapy or radiation therapy
• Concurrent disease precluding protocol treatment as defined in the protocol
• Pregnancy or breast-feeding
• Non-compliance as defined in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

MeSH Terms

Conditions

Hodgkin Disease

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: May 4, 2020
• Study Start: November 15, 2020
• Primary Completion: December 20, 2022
• Study Completion: February 20, 2025
• Last Updated: January 15, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency \[EMA\], Pharmaceuticals and Medical Devices Agency \[PMDA\], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).