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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response rate autologous stem cell transplantation assessed by Lugano criteria
Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Secondary outcome measures
Non-relapse mortality
Overall response rate
Overall survival
+4 more
Other outcome measures
Role of PDL1/L2, CD68 on lymphoma specimens
Role of T/B/natural killer cell subsets in the peripheral blood

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

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
~2980
Nivolumab
2014
Completed Phase 3
~4750
Carboplatin
2014
Completed Phase 3
~6670
Etoposide
2010
Completed Phase 3
~2440

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,374 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,568 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Medical Center
11 Previous Clinical Trials
1,483 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03016871 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Cohort A (nivolumab, etoposide, ifosfamide, carboplatin), Cohort B (nivolumab, etoposide, ifosfamide, carboplatin)
Hodgkin's Lymphoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03016871 — Phase 2
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03016871 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Nivolumab for use?

"Given the lack of proof for efficacy, but some evidence in support of safety, Nivolumab was assessed as having a security rating of 2."

Answered by AI

What has Nivolumab been historically employed for?

"Nivolumab is an effective therapeutic intervention against malignant melanoma of skin, merkel cell cancer, and leukemia."

Answered by AI

Are there opportunities available for individuals to join this research project?

"Unfortunately, no longer are participants being actively sought for this study which was initially posted on April 24th 2017. The information last updated on October 24th 2022. Fortunately, there remain 1723 clinical trials looking to enrol hodgkin disease patients and 2186 studies recruiting for Nivolumab treatment at present."

Answered by AI

How extensive is the participant pool for this experiment?

"The recruitment period for this trial has ended. Initially posted on April 24th 2017 and last updated October 24th 2022, the study is no longer accepting enrolment. For those searching for alternative studies, there are 1723 trials actively recruiting hodgkin disease patients and 2186 clinical trials admitting participants with Nivolumab treatment needs."

Answered by AI

Has there been any previous research involving Nivolumab?

"Presently, there are 2186 ongoing studies for Nivolumab and 436 of them have reached Phase 3. Most trials are concentrated in Leesburg, Virginia; however, a total of 102786 locations worldwide participate in the research related to this drug."

Answered by AI

What objectives are being pursued by this research endeavor?

"The duration of this trial is expected to last up to 2 years and the primary goal will be evaluating the efficacy of autologous stem cell transplantation according to Lugano criteria. Secondary outcomes include overall response rate, relapse/progression event, and overall survival; all evaluated with Kaplan-Meier estimations."

Answered by AI

How many healthcare institutions are currently conducting this clinical trial?

"This clinical trial is being conducted at Yale University in New Haven, Connecticut, City of Hope Medical Center in Duarte, California and M D Anderson Cancer Centre in Houston Texas as well as 4 additional institutions."

Answered by AI
~8 spots leftby Jan 2025