NIVAHL: Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma

• Sponsor: University of Cologne (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03004833
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 69.3
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The aim of the trial is to improve first-line treatment for early unfavorable cHL by introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy (AVD).

The primary objective is to show efficacy of the two experimental treatment strategies. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.

Condition or Disease	Intervention/Treatment	Phase
Classical Hodgkin Lymphoma	Drug: Nivolumab; Drug: Adriamycin; Drug: Vinblastine; Drug: Dacarbazine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
• Actual Study Start Date: Feb 21, 2017
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A 4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)	Drug: Nivolumab; Infusion of Nivolumab; Drug: Adriamycin; Infusion of Adriamycin; Drug: Vinblastine; Infusion of Vinblastine; Drug: Dacarbazine; Infusion of Dacarbazine
Experimental: Arm B 4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)	Drug: Nivolumab; Infusion of Nivolumab; Drug: Adriamycin; Infusion of Adriamycin; Drug: Vinblastine; Infusion of Vinblastine; Drug: Dacarbazine; Infusion of Dacarbazine

Outcome Measures

Primary Outcome Measures

1. Complete Remission Rate [4 to 6 weeks after end of treatment]

Secondary Outcome Measures

1. Treatment related Morbidity [1 year after end of treatment]

2. Progression Free Survival [1 and 3 years after end of treatment]

3. Overall Survival [1 and 3 years after end of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically proven classical HL

• First diagnosis, no previous treatment

• Age: 18-60 years

• Stage I, IIA with risk factors a-d, IIB with RF c-d:

1. large mediastinal mass

2. extranodal lesions

3. elevated ESR

4. ≥ 3 nodal areas confirmed by central review.

Exclusion Criteria:

• Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)

• History of other malignancy ≤ 5 years

• Prior chemotherapy or radiation therapy

• Concurrent disease precluding protocol treatment

• Pregnancy, lactation

• Non-compliance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Cologne	Cologne		Germany

Sponsors and Collaborators

• University of Cologne

Investigators

• Principal Investigator: Andreas Engert, Prof., University of Cologne, I. Dept. of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Prof. Dr. Andreas Engert, Prof., University of Cologne
• ClinicalTrials.gov Identifier: NCT03004833
• Other Study ID Numbers: Uni-Koeln-2854
• First Posted: Dec 29, 2016
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Hodgkin Disease; Nivolumab; Doxorubicin; Liposomal doxorubicin; Dacarbazine; Vinblastine

Study Results

No Results Posted as of Aug 8, 2022