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Chemotherapy

Nivolumab + Chemotherapy for Hodgkin's Lymphoma

Phase 2

Waitlist Available

Led By Alex F Herrera

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Male subjects must use contraception if sexually active with women of childbearing potential

Must not have

Prior exposure to PD-1 or PD-L1 inhibitors is not allowed

Patients should not have any uncontrolled illness including ongoing or active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of transplant to time of progression, death (due to any cause), or last contact, whichever comes first, assessed 2 years post-transplant, up to 3 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing nivolumab in combination with ifosfamide, carboplatin, and etoposide to treat patients with Hodgkin lymphoma that has come back and does not respond to treatment.

Who is the study for?

This trial is for patients with Hodgkin lymphoma that has returned or doesn't respond to treatment. They must have a life expectancy over 3 months, adequate blood counts, weigh more than 40 kg, and have an ECOG performance status of 0-2. Patients should be relapsed after one line of therapy or refractory to initial therapy. Exclusions include allergies to study drugs, other recent cancers or treatments, certain heart conditions, active infections including HIV/HBV/HCV, and pregnant or breastfeeding women.

What is being tested?

The trial tests the effectiveness and side effects of combining nivolumab (an immunotherapy drug) with chemotherapy drugs ifosfamide, carboplatin, and etoposide in those with relapsed/refractory Hodgkin lymphoma. It's a phase II study aiming to see how well this combination helps the immune system attack cancer cells and stop their growth.

What are the potential side effects?

Potential side effects may include immune-related reactions due to nivolumab affecting organs like lungs (pneumonitis), liver toxicity from hepatitis risk factors; common chemo side effects such as nausea/vomiting; low blood cell counts leading to increased infection risk; fatigue; hair loss; kidney damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of the day.

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I am a man and will use birth control if I'm with a woman who can have children.

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My liver function tests are within the required limits for Hodgkin lymphoma.

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I weigh more than 40 kg.

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My Hodgkin lymphoma has been confirmed and shows CD30 expression.

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I have a tumor larger than 1.5 cm confirmed by a CT or PET scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been treated with PD-1 or PD-L1 inhibitors.

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I do not have any uncontrolled illnesses or active infections.

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I have a history of HIV, HCV, or HBV infection.

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I understand the study's purpose and risks and can give informed consent.

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I finished treatment for an infection less than 14 days ago.

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I have not received second-line chemotherapy for Hodgkin lymphoma.

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I am receiving treatment for an active autoimmune disease.

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I have active brain issues or a history of brain cancer spread.

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I am willing and able to follow all study requirements.

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I haven't had a heart attack in the last 6 months and don't have severe heart issues.

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I do not have any severe illnesses that could risk my safety or affect the study's results.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of transplant to time of progression, death (due to any cause), or last contact, whichever comes first, assessed 2 years post-transplant, up to 3 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of transplant to time of progression, death (due to any cause), or last contact, whichever comes first, assessed 2 years post-transplant, up to 3 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of transplant to time of progression, death (due to any cause), or last contact, whichever comes first, assessed 2 years post-transplant, up to 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response Rate by Lugano Classification

Number of Participants With Unacceptable Adverse Events

Secondary study objectives

Cumulative Incidence of Relapse/Progression at 2 Years

Non-relapse Mortality (NRM) at 2 Years

Overall Response Rate

+3 more

Other study objectives

Role of PDL1/L2, CD68 on lymphoma specimens

Role of T/B/natural killer cell subsets in the peripheral blood

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717

80%

Fatigue

70%

Diarrhoea

70%

Headache

40%

Vomiting

40%

Aspartate aminotransferase increased

40%

Rash maculo-papular

40%

Alanine aminotransferase increased

40%

Lipase increased

30%

Partial seizures

30%

Hemiparesis

30%

Gait disturbance

30%

Fall

30%

Cough

30%

Dry skin

30%

Amylase increased

30%

Nausea

30%

Confusional state

20%

Malignant neoplasm progression

20%

Pyrexia

20%

Candida infection

20%

Mucosal infection

20%

Decreased appetite

20%

Back pain

20%

Dysphonia

20%

Hypotension

20%

Colitis

20%

Hyperthyroidism

20%

Oedema peripheral

20%

Muscular weakness

20%

Hypothyroidism

10%

Tinnitus

10%

Cushingoid

10%

Diabetic ketoacidosis

10%

Procedural haemorrhage

10%

Blood bilirubin increased

10%

Bradycardia

10%

Sinus tachycardia

10%

Hyperglycaemia

10%

Hypocalcaemia

10%

Neck pain

10%

Brain oedema

10%

Hydrocephalus

10%

Lethargy

10%

Seizure

10%

Hypertension

10%

Palpitations

10%

Cheilitis

10%

Presyncope

10%

Face oedema

10%

Oedema

10%

Conjunctivitis

10%

Enterocolitis infectious

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Staphylococcal infection

10%

Blood alkaline phosphatase increased

10%

Spinal pain

10%

Tremor

10%

Dizziness

10%

Dysarthria

10%

Urinary retention

10%

Dyspnoea exertional

10%

Nasal congestion

10%

Pneumonitis

10%

Dermatitis

10%

Erythema

10%

Rash

10%

Klebsiella infection

10%

Hypomagnesaemia

10%

Syncope

10%

Haemorrhage intracranial

10%

Pancreatitis

10%

Cholecystitis

10%

Upper respiratory tract infection

10%

Acute kidney injury

10%

Dermatitis bullous

10%

Lymphopenia

10%

Optic nerve disorder

10%

Visual impairment

10%

Dehydration

10%

Hypokalaemia

10%

Scoliosis

10%

Cognitive disorder

10%

Memory impairment

10%

Hallucination

10%

Insomnia

10%

Irritability

10%

Urinary incontinence

10%

Dyspnoea

10%

Dermatitis acneiform

10%

Pelvic venous thrombosis

10%

Sepsis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1: Arm N1+I3

Cohort 2: Arm B

Part A Cohort 1c: Arm N3+RT+TMZ

Part A Cohort 1d: Arm N3+RT

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Cohort 1: Arm N3

Cohort 1b: Arm N3+I1

Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B (nivolumab, etoposide, ifosfamide, carboplatin)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on cycle 1 (cycle 1 is 14 days), day 1 in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

Group II: Cohort A (nivolumab, etoposide, ifosfamide, carboplatin)Experimental Treatment5 Interventions

Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 14 days for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive nivolumab for an additional 6 weeks. Patients with only SD after 6-week nivolumab treatment receive nivolumab for an additional 6 weeks or receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2 every 21 days for 6 weeks per physician/investigator's discretion. Patients with PD after 6-week nivolumab treatment or patients with PR, SD, or PD after 12-week nivolumab treatment receive nivolumab IV over 30 minutes on day 1, etoposide IV on days 1-3, ifosfamide IV continuously over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ifosfamide

2010

Completed Phase 4

~3350

Nivolumab

2015

Completed Phase 3

~4010