OncoMatch/Clinical Trials/NCT04866654
Radiation Free Chemotherapy for Early Hodgkin Lymphoma
Is NCT04866654 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Nivolumab 10 MG/ML for hodgkin lymphoma.
Treatment: Nivolumab 10 MG/ML — The results of the present study will provide information on short-term safety and efficacy of a iPET and MTV-adapted therapeutic strategy, aimed to assess the feasibility and safety on immediate disease control of a standard ABVD chemotherapy without any further treatment in patients with a very low risk or treatment failure. A second very important endpoint will be the efficacy of INRT "on demand" followed by Nivolumab maintenance for one year to rescue patients failing first-line treatment and relapsing with the pattern of "limited relapse" in terms of 3-Y failure from 2 relapse (FF2R). Patients entering into the study will be also asked to participate to a long-term follow up study (beyond ten years) to assess the prevalence of late-onset cardiovascular effects and secondary tumors in the cohort of patients enrolled in the experimental and control arm of the study. An exploratory endpoint has been also added such as the role of Minimal Residual Disease (MRD) detection by cell-free DNA assay on peripheral blood samples obtained during treatment in predicting long-term disease control.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Hodgkin Lymphoma
Disease stage
Required: Stage I, II
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Lab requirements
Blood counts
Hemoglobin > 8 gr./dL; Absolute neutrophil count ≥ 1,000/μL; Platelet count ≥ 100,000/μL
Kidney function
Serum Creatinine < 2.0 mg/dL and/or Creatinine clearance or calculated Creatinine clearance > 40 mL/minute
Liver function
Total bilirubin must be < 2.0 x ULN unless known Gilbert syndrome; ALT or AST must be < 3 x ULN
Cardiac function
A left-ventricular ejection fraction < 50% [excluded]; Myocardial infarction within 2 years of study entry [excluded]
Hemoglobin must be > 8 gr./dL; Absolute neutrophil count ≥ 1,000/μL; Platelet count ≥ 100,000/μL; Serum Creatinine < 2.0 mg/dL and/or Creatinine clearance or calculated Creatinine clearance > 40 mL/minute; Total bilirubin must be < 2.0 x ULN unless known Gilbert syndrome; ALT or AST must be < 3 x ULN; A left-ventricular ejection fraction < 50% [excluded]; Myocardial infarction within 2 years of study entry [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04866654 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage I or II is required.
Is there an age limit?
Yes. Patients must be 60 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages