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New treatment option for Hodgkin Lymphoma
Official title PET-Adapted First-Line Therapy With Nivolumab for Advanced Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT07209059
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, being studied as a potential treatment for hodgkin lymphoma.
Also referred to as Opdivo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, open-label, phase 2 pilot study evaluating the efficacy and safety of a response-adapted first-line treatment strategy for patients with classical Hodgkin lymphoma (cHL) and unfavorable prognostic factors. The FINISH protocol (First-line Immuno-chemotherapy Navigated by Interim PET for Stratification and Hazard minimization In Hodgkin lymphoma) integrates nivolumab into induction therapy and tailors subsequent treatment based on interim PET-CT response.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Signed written informed consent prior to any study-specific procedures
- Histologically confirmed classical Hodgkin lymphoma (cHL)
- Newly diagnosed disease, Ann Arbor stage IIB (bulky), III, or IV
- At least one measurable lesion ≥15 mm in the longest diameter (by CT)
- Age between 18 and 60 years (inclusive)
You likely can't join if
- Active hepatitis B or C infection
- Positive test for HIV
- Pregnancy or breastfeeding
- Prior or active autoimmune disease requiring systemic therapy
- Vaccination with a live vaccine within 30 days prior to first nivolumab dose
- History of non-infectious pneumonitis requiring corticosteroids
See the full eligibility criteria
- Signed written informed consent prior to any study-specific procedures
- Histologically confirmed classical Hodgkin lymphoma (cHL)
- Newly diagnosed disease, Ann Arbor stage IIB (bulky), III, or IV
- At least one measurable lesion ≥15 mm in the longest diameter (by CT)
- Age between 18 and 60 years (inclusive)
- ECOG performance status 0-2
- PET-CT performed at baseline
- No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma
- Adequate organ function, including:
- Serum creatinine ≤ 0.2 mmol/L
- Absence of severe cardiac, pulmonary, hepatic, or renal dysfunction
- Ability to comply with the study protocol and scheduled visits
- Active hepatitis B or C infection
- Positive test for HIV
- Pregnancy or breastfeeding
- Prior or active autoimmune disease requiring systemic therapy
- Vaccination with a live vaccine within 30 days prior to first nivolumab dose
- History of non-infectious pneumonitis requiring corticosteroids
- Prior malignancy (except for adequately treated basal cell carcinoma or cervical carcinoma in situ)
- Congestive heart failure, unstable angina, recent myocardial infarction, or severe cardiac arrhythmias
- Severe renal impairment (serum creatinine \> 0.2 mmol/L), unless lymphoma-related
- Severe hepatic dysfunction, unless directly related to lymphoma
- Severe pneumonia with respiratory failure or hypoxemia not corrected within 2-3 days
- Sepsis or hemodynamic instability
- Life-threatening bleeding events (e.g., gastrointestinal or cerebral hemorrhage)
- Cachexia (total serum protein \< 35 g/L), unless due to lymphoma-related liver damage
- Decompensated diabetes mellitus
- Any somatic or psychiatric condition that, in the investigator's judgment, precludes informed consent or study participation
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.