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Nivolumab for Hodgkin's Lymphoma

Phase 2
Waitlist Available
Research Sponsored by SCRI Development Innovations, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 weeks up to a maximum of 6 months of treatment, then up to 100 days after treatment discontinuation
Awards & highlights

Study Summary

This trial is testing nivolumab as a maintenance therapy for Hodgkin lymphoma patients who are at risk of relapse or progression after having an autologous stem cell transplant.

Eligible Conditions
  • Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 weeks up to a maximum of 6 months of treatment, then up to 100 days after treatment discontinuation
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 weeks up to a maximum of 6 months of treatment, then up to 100 days after treatment discontinuation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of Nivolumab as Maintenance Therapy
Secondary outcome measures
Progression-free Survival (PFS) Kaplan-Meier Estimate at 12 Month Interval

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%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Hypertension
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
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%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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

1Treatment groups
Experimental Treatment
Group I: NivolumabExperimental Treatment1 Intervention
Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,526 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,477 Total Patients Enrolled
Carlos Bachier, MDStudy ChairSCRI Development Innovations, LLC
1 Previous Clinical Trials
9 Total Patients Enrolled

Frequently Asked Questions

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

Has Nivolumab been subject to prior exploratory research?

"Nivolumab's first clinical trial was launched in 2012 at Local Institution. After 252 completed studies, there are currently 718 active trials involving this medication - many of them occurring near San Antonio, Texas."

Answered by AI

Where are the locations of this experiment being conducted?

"This medical investigation is being conducted in multiple locations, including the Texas Transplant Institute in San Antonio, Tennessee Oncology in Nashville and HCA Midwest located Kansas City. There are three additional sites involved as well."

Answered by AI

How many participants have signed up to join this research endeavor?

"Unfortunately, this trial is not presently enrolling new patients as its last edit was on May 10th 2022. However, if you are searching for other trials that may be of interest to you, there are a total of 1725 studies related to lymphoma and 718 studies involving nivolumab currently recruiting participants."

Answered by AI

Does this investigation introduce any new protocols or avenues of research?

"Nivolumab has been under the microscope since 2012, when Ono Pharmaceutical Co. Ltd sponsored its very first clinical trial involving 659 patients. After that initial research, Nivolumab was approved for Phase 1 & 2 drug trials and is currently being researched in 718 live trials across 49 countries and 2356 cities."

Answered by AI

Is there still an opportunity to enlist in this clinical trial?

"At present, no more patients are being accepted into this clinical trial. Its initial posting occured on May 23rd 2018 and its most recent edit was made on May 10th 2022. If you desire to join another medical study there are 1725 trials for lymphoma and 718 trials related to Nivolumab recruiting participants currently."

Answered by AI

Has the FDA accepted Nivolumab as a viable therapeutic option?

"Nivolumab was determined to have a score of 2 on the safety scale, due to evidence-based guidance only regarding its security profiles and lack thereof in terms of efficacy."

Answered by AI

What ailments can Nivolumab be deployed to address?

"Nivolumab is frequently utilized for the treatment of malignant neoplasms, though it can also be beneficial when managing unresectable melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk
2018. "Nivolumab Maintenance Therapy After Autologous Stem Cell Transplant in Hodgkin Lymphoma Pts at Relapse/Progression Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03436862.
~5 spots leftby Apr 2025
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