Phase II Trial of Anti-PD-1 Antibody Treatment and Radiot... | NCT06916416

Studies
Phase II Trial of Anti-PD-1 Antibody Treatment and Radiotherapy in Early-stage Favorable Classic Hodgkin Lymphoma

NCT06916416

Sponsor

University of Cologne

Status

Not yet recruiting

Last Update Posted

Apr 8, 2025Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Classical Hodgkin Lymphoma

Interventions

Pembrolizumab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2024-520138-31-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2025Estimated

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2028Estimated

First Submitted Date

Mar 31, 2025

First Submission Date that Met QC Criteria

Mar 31, 2025

First Posted Date

Apr 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2025

Last Update Posted Date

Apr 8, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

By the implementation of the anti-PD-1 antibody pembrolizumab and given its possible synergy with RT, the aim of the present trial is to develop a chemotherapy-free first-line treatment for patients with newly diagnosed early-stage favorable cHL.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pembrolizumab	Experimental	All patients will receive 6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by 20Gy radiotherapy	Drug: Pembrolizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Drug	6 doses of 200mg Pembrolizumab iv as single agent every three weeks followed by radiotherapy 20Gy	Pembrolizumab

Measure	Description	Time Frame
Progression Free Survival		PFS at 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proven first diagnosis of cHL
Stage I-II without risk factors
- Large mediastinal mass
- Extranodal involvement
- Elevated erythrocyte sedimentation rate (ESR)
- Involvement of ≥ 3 nodal areas

Exclusion Criteria:

Central nervous system lymphoma, nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma,
Prior cHL-directed treatment
Prior chemotherapy, RT or allogeneic stem cell/solid organ transplant
Prior or concurrent disease precluding protocol treatment (for details see section 4.2)
Pregnancy or breastfeeding
Non-compliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Fuchs	Contact	+49221478	88160	michael.fuchs@uk-koeln.de

Overall Officials

Name	Affiliation	Role
Dennis Eichenauer, Dr.	University Hospital of Cologne	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C582435	pembrolizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided