Nivo40-AVD for Advanced Classic Hodgkin Lymphoma | NCT06984146

Studies
Nivo40-AVD for Advanced Classic Hodgkin Lymphoma

NCT06984146

Sponsor

National Medical Research Radiological Centre of the Ministry of Health of Russia

Status

Recruiting

Last Update Posted

Nov 26, 2025Actual

Enrollment

54Estimated

Phase

Phase 2

Conditions

Hodgkin Lymphoma, Adult

Interventions

Nivolumab
Doxorubicin
Vinblastine
Dacarbazine

Countries

Russia

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

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2025Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

May 2, 2025

First Submission Date that Met QC Criteria

May 19, 2025

First Posted Date

May 22, 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

Nov 20, 2025

Last Update Posted Date

Nov 26, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of the current trial is to evaluate the efficacy and safety of flat-dose nivolumab (40 mg) in combination with AVD in the management of patients with newly diagnosed advanced classic Hodgkin Lymphoma

Detailed Description

Patients will receive 6 cycles of Nivo40-AVD with interim and EOT PET/CT scan. Interim PET/CT will not affect clinical decisions and is done as part of the study on response predictors after first line PD-1 inhibitor therapy. In patients achieving only partial metabolic response after 6 cycles (Deauville score ≥ 4) radiation therapy is allowed.

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

54Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nivo40-AVD	Experimental	Nivolumab 40 mg IV day 1 and 15; Doxorubicin 25 mg/m2 IV day 1 and 15; Vinblastine 6 mg/m2 IV day 1 and 15; Dacarbazine 375 mg/m2 day 1 and 15	Drug: Nivolumab Drug: Doxorubicin Drug: Vinblastine Drug: Dacarbazine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug	40 mg day 1 and 15	Nivo40-AVD
Doxorubicin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival		2 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival		2 years
Complete remission and complete metabolic response		2 years
Adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly-diagnosed histologically verified advanced stage (IIB-IV as per GHSG) classic Hodgkin lymphoma
No past history of autoimmune disease
Age > 18 years
Ejection fraction > 50%
ECOG 0-4

Exclusion Criteria:

Organ failure (e.g. creatinine > 2x ULN; ALT or AST > 5x ULN; bilirubin > 2x ULN; hemodynamic instability; respiratory failure > Grade 1)
Uncontrolled infection
Pregnancy
Inability to sign informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mobil Akhmedov, MD, PhD	Contact	79261802399		mobilakhmedov@gmail.com

Overall Officials

Name	Affiliation	Role
Andrey Kaprin	FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
P. Hertsen Moscow Oncology Research Institute (MORI) for administrative and economic work - the branch of the FSBI "National Medical Research Radiological Centre" (NMRRC) of the Ministry of Health of the Russian Federation	Recruiting	Moscow

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Individual patient data might not be shared to protect patient privacy and confidentiality. All other information regarding the study will be published in detail

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077594	Nivolumab
D004317	Doxorubicin
D014747	Vinblastine
D003606	Dacarbazine

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided