A study of nivolumab alone, or in combination with vinblastin in patients aged 61 years and older, with Hodgkin Lymphoma

Phase 1

Conditions: patients aged 61 years and older, with classical Hodgkin lymphoma and coexisting medical conditions
MedDRA version: 20.1Level: LLTClassification code 10080208Term: Classical Hodgkin lymphomaSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-001939-38-BE

Lead Sponsor: YSARC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

- Having a first diagnosis of classical Hodgkin lymphoma
- Age 61 years or older
- Unfit for polychemotherapy
- No previous treatment for Hodgkin lymphoma
- Ann Arbor stages: I-IV
- Baseline 18-FDG PET-CT (PET0) performed before any treatment with at least one hypermetabolic lesion
- A minimum life expectancy of 3 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

- Contra-indication to Nivolumab and /or vinblastin
- Subjects with active interstitial pneumonitis
- Subjects with active infectious disease
- Subjects with active, known or suspected autoimmune disease
- Any serious active disease, severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment (according to the investigator’s decision)
- Any of the following abnormal laboratory values :
a. Calculated creatinine clearance < 30 mL/min (MDRD formula)
b. AST or ALT > 2.5 times the upper limit of normal (ULN)
c. Serum total bilirubin > 30µmol/L
d. Neutrophils<1G/L or Platelets<50G/L, (unless related to bone infiltration by lymphoma)
- Any history of cancer evolution requiring therapy during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if :
a. Their disease was T1-T2a, N0, M0, with a Gleason score = 7, and a prostate specific antigen (PSA) = 10 ng/mL prior to initial therapy,
b. They had definitive curative therapy (ie, prostatectomy or radiotherapy) = 2 years before Day 1 of Cycle 1,
c. At a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
- Uncontrolled diabetes mellitus leading to impossibility to perform PET scan
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- Adult person under legal protection
- Adult person unabled to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
- Documented infection with HIV
- Subjects with known active hepatitis C infection (patients with positive HCV serology are eligible only if PCR is negative for known HCV RNA)
or subjects with known Active hepatitis B :
a. HBsAg positive
b. HBsAg negative, Ac anti-HBs positive and/or Ac anti-HBc positive (Patients who are seropositive due to a history of hepatitis B vaccine are eligible. Patients with Ac anti-HBs positive and/or Ac anti-HBc positive and no history of hepatitis B vaccine are eligible only if PCR for VHB DNA is negative)
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the Complete Metabolic Response (CMR) rate by the Lugano classification 2014 at the end of treatment.;Secondary Objective: • To assess the feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay)<br>• To assess the safety profile of Nivolumab alone or combined with Vinblastin including immediate toxicities and non tumor events<br>• To assess progression-free survival (PFS), event-free survival (EFS), and overall survival (OS)<br>• To assess Complete Metabolic Response (CMR) rate by the Lugano classification 2014 at the end of induction treatment<br>• To perform a geriatric assessment program (G8, CIRS-G);Primary end point(s): To assess the Complete Metabolic Response (CMR) rate by the Lugano classification 2014;Timepoint(s) of evaluation of this end point: at the end of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Feasibility<br>- Progression free survival<br>- Event free Survival<br>- Overall survival<br>- Complete response rates at end of induction treatment<br>- Safety endpoints<br>- Geriatric assessment;Timepoint(s) of evaluation of this end point: - Feasibility<br>- Progression free survival: from first nivolumab dose into the study to the first observation of documented disease progression/relapse or death due to any cause<br>- Event free Survival: from the date of first nivolumab dose to the date of first documented disease progression/relapse, initiation of new anti-lymphoma therapy or death from any cause. <br>- Overall survival: from date of first nivolumab dose into the study to the date of death from any cause<br>- Complete response rates at end of induction treatment: at end of induction treatment<br>- Safety endpoints: throughout the study<br>- Geriatric assessment: at baseline

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