To see the effect Drug Nivolumab in low dose for treating cancer

Phase 3

Conditions: Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Registration Number: CTRI/2024/03/063942

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Newly diagnosed advanced stage HL (as per GHSG criteria) with a PET scan done within previous one month.

Age above 12years

Advanced stage includes the following:

Stage IIB with mediastinum-to-thorax ratio above 0.33 or above 10cm or extra-nodal disease

Stage III A or B

Stage IV A or B

Exclusion Criteria

Previous chemotherapy received (steroid pre-treatment is permitted)

Pregnancy

ECOG above 3

ECHO EF less than 50%

Creatinine clearance above 30mL/mt

Hepatitis B, C negative [Hep B, Hep C and HIV positive permitted if viral load is undetectable]

History of autoimmune disease (autoimmune hepatitis, inflammatory bowel disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis, motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis).

Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the early treatment failure (iPET2 with Deauville score above 3), disease progression, relapse or death at any time-point.Timepoint: after 2 weeks <br/ ><br>after 8 weeks <br/ ><br>after 1 year <br/ ><br>after years

Secondary Outcome Measures

Name	Time	Method
1)iPET-2 negative rate defined as FDG-PET/CT with a Deauville score of 1-3 [taken 2 weeks after completion of cycle 2B of chemotherapy] <br/ ><br>2)Complete response rate after 6 cycles of chemotherapy defined as FDG-PET/CT with a Deauville score of 1-3 [taken 6-8 weeks after completion of cycle 6B] <br/ ><br>3)Partial response rate defined as Deauville score 4 or 5 (reduced uptake compared with baseline and no new lesions) [taken 6-8 weeks after completion of cycle 6B] <br/ ><br>4)Incidence and severity of adverse effects (haematological toxicity, immune-related adverse events and bleomycin toxicity) <br/ ><br>5)Progression-free survival at 2 years defined as time to relapse/progression, death, or subsequent therapy (systemic cancer therapy or transplantation). <br/ ><br>6)Overall survival at 2 years <br/ ><br>Timepoint: 2 weeks <br/ ><br>6 to 8 weeks <br/ ><br>3 months <br/ ><br>6 months <br/ ><br>12 months <br/ ><br>24 months