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Checkpoint Inhibitor

Ipilimumab +/− Nivolumab for Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Reid W Merryman, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically determined classic Hodgkin lymphoma with pathologic review at the participating institution
Patients must have progressed after two or more lines of systemic treatment, including autologous stem cell transplantation, if eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is studying the effects of two drugs on patients with a specific type of cancer that has returned or does not respond to treatment.

Who is the study for?
Adults over 18 with relapsed or refractory classic Hodgkin's lymphoma, who have measurable disease and have progressed after two or more systemic treatments including a stem cell transplant if eligible. They must not have certain infections, severe allergies to monoclonal antibodies, recent major surgeries, uncontrolled medical conditions, active pneumonitis or colitis, other cancers within the last 2 years (with some exceptions), and should agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Ipilimumab alone versus in combination with Nivolumab for patients whose Hodgkin's lymphoma has returned or hasn't responded to treatment. It aims to see which approach is better at controlling the disease.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in organs like lungs and intestines (pneumonitis/colitis), fatigue, skin issues like rash or itching, hormonal gland problems (like thyroid dysfunction), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My Hodgkin lymphoma diagnosis was confirmed through tissue examination.
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My condition worsened after at least two treatments, including a stem cell transplant if I was eligible.
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I am able to get out of my bed or chair and move around.
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I have a tumor or lymph node that is at least 1.5 cm big, confirmed by a recent scan.
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My blood counts and organ functions are within normal ranges.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Overall response rate (ORR) after 4 cycles of ipilimumab monotherapy
Secondary outcome measures
Complete Response rate (CRR) Ipilimumab monotherapy
Complete Response rate (CRR) ipilimumab and nivolumab combination therapy
Duration of Response ipilimumab and nivolumab combination therapy
+8 more

Side effects data

From 2017 Phase 3 trial • 1289 Patients • NCT01285609
38%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung neoplasm malignant
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Disease Progression after previous therapyExperimental Treatment2 Interventions
Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable. Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,973 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,019 Total Patients Enrolled
Reid W Merryman, MDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04938232 — Phase 2
Hodgkin's Lymphoma Research Study Groups: Disease Progression after previous therapy
Hodgkin's Lymphoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04938232 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04938232 — Phase 2

Frequently Asked Questions

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

Is there a limit to the number of participants accepted for this medical experiment?

"Yes, the research is still active as per clinicaltrials.gov's records. The trial was initially announced on June 4th 2021 and has been modified for the last time on October 18th 2022. 32 participants need to be recruited across 3 sites."

Answered by AI

Has the Food and Drug Administration approved Ipilimumab for use?

"Our analysts at Power gave Ipilimumab a score of 2 on the safety scale, as this Phase 2 clinical trial has evidence that suggests its safety but not necessarily its effectiveness."

Answered by AI

What are the primary medical conditions that Ipilimumab has been utilized to address?

"Ipilimumab is often used to treat anti-angiogenic therapy, but can also be beneficial for patients with malignant neoplasms, melanoma that cannot be surgically removed, and squamous cell carcinoma."

Answered by AI

Are any individuals being enrolled in this clinical experiment at present?

"Affirmative. Details made available on clinicaltrials.gov suggest that recruitment for this trial is currently underway, having been first posted on June 4th 2021 and recently updated on October 18th 2022. 32 patients are needed at 3 different medical sites."

Answered by AI

What are the chief aims of this experiment?

"The primary objective of this trial, which should be completed in 6 months or so, is to measure the Overall Response Rate (ORR) for patients undergoing 4 cycles of ipilimumab monotherapy -Cohort 2. Secondary objectives include Best ORR-Cohort 1 based on PET/CT scans and their Lugano and LYRIC criteria; ORR after Ipilimumab Monotherapy-Cohort 2 with reference to those same criteria; and ORR from Ipilimumab plus Nivolumab Combination Therapy- Cohort2 also assessed by PET/CT under the aforementioned standards."

Answered by AI

Has there been any other research conducted around the potential of Ipilimumab?

"Currently, there are 86 Phase 3 clinical trials in progress for Ipilimumab with 765 total studies ongoing. While many of the research sites can be found in Pittsburgh, Pennsylvania, 42755 locations across the globe are researching this drug."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL
Reid Merryman, MD 2021. "Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04938232.
~3 spots leftby Apr 2025
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