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Anti-tumor antibiotic
A(B)VD + Nivolumab for Hodgkin's Lymphoma
Phase 1 & 2
Recruiting
Led By Alison Moskowitz, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18
Serum creatinine ≤ 1.5 x Upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL/min (measured using the Cockcroft-Gault formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
Study Summary
This trial is testing a new cancer treatment for Hodgkin lymphoma. The goal is to see if it can improve the chances of a cure, especially for patients with higher risk Hodgkin lymphoma.
Who is the study for?
This trial is for adults with untreated classical Hodgkin lymphoma who are at higher risk (stage III or IV, or positive PET scans after initial treatment). It's open to those under 60 for one cohort and over 60 for another. Participants need functioning major organs, not be pregnant or breastfeeding, and must use reliable birth control.Check my eligibility
What is being tested?
The study is testing the effectiveness of Nivolumab combined with a chemotherapy regimen called ABVD (which includes dacarbazine, doxorubicin, bleomycin, vinblastine) as a first-line treatment to see if it can improve cure rates in patients with high-risk Hodgkin lymphoma.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs due to Nivolumab. Chemotherapy drugs may cause nausea, hair loss, fatigue, increased infection risk and heart complications among other side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
Select...
I have been diagnosed with classical Hodgkin lymphoma.
Select...
My condition is in an advanced stage, specifically Ann Arbor Stage III or IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase II- progression free survival
number of patients who have dose limiting toxicity
Side effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest 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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Syncope
1%
Cancer pain
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
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
2Treatment groups
Experimental Treatment
Group I: < 60 years of age with advanced stage (HL) untreatedExperimental Treatment5 Interventions
The study will employ a 3+3 design and include 3 treatment cohorts. In each cohort, patients will receive 6 cycles of A(B)VD and 8 doses of nivolumab. In dose level 1, patients will receive nivolumab in combination with AVD during cycle 6 only followed by 6 additional doses of nivolumab. In subsequent dose levels, nivolumab will be combined with increasing numbers of cycles of AVD. Based upon safety data from another study with Nivolumab, we will no longer need to evaluate dose level 2. If we determine that dose level 1 is safe, the next group of patients will enroll onto dose level 3. A PET scan will be performed after 2 cycles of ABVD and those with a PET-negative response (defined by Deauville 1, 2 or 3) will proceed with 4 additional cycles of ABVD or AVD (per treating physician preference).
Group II: 60 years of age and older with HL (any stage) untreatedExperimental Treatment4 Interventions
The study will employ a 3+3 design and include 3 treatment cohorts. In each cohort, patients will receive 6 cycles of AVD and 12 doses of nivolumab. In this cohort, patients will receive nivolumab in combination with AVD during cycles 5 and 6 only, followed by 8 additional doses of nivolumab. In subsequent cohorts, nivolumab will be combined with increasing numbers of cycles of AVD. Based upon safety data from another study with Nivolumab, we will no longer need to evaluate dose level 2. If we determine that dose level 1 is safe, the next group of patients will enroll onto dose level 3. Prophylactic growth factor support is mandatory for all patients on Cohort B and should be used per the treating physician's discretion for all other patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
doxorubicin
2005
Completed Phase 3
~9130
dacarbazine
2010
Completed Phase 3
~5030
Bleomycin
2001
Completed Phase 3
~4960
vinblastine
2010
Completed Phase 3
~1490
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,383 Total Patients Enrolled
British Columbia Cancer AgencyOTHER
171 Previous Clinical Trials
90,430 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,817 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I haven't had serious heart issues in the last 6 months.My heart's pumping ability is below normal.I do not have uncontrolled heart problems.I am 60 or older with untreated classical Hodgkin lymphoma.I haven't had active cancer in the last 3 years, except for certain curable types.I agree to use contraception during and for 31 weeks after treatment if I'm sexually active with a woman who can become pregnant.I am under 60 with stage III or IV Hodgkin lymphoma, untreated, and qualify for cohort A.I have an autoimmune disease but it's under control or one of the exceptions listed.I am on steroids but can reduce to 10mg or less if needed for treatment.I am not pregnant or have taken steps to preserve fertility before starting chemotherapy.I am not pregnant or have taken steps to preserve fertility before starting chemotherapy.I am using effective birth control or practicing total abstinence during the study.My kidney function, measured by creatinine levels, is within the normal range.I am under 60 with stage III or IV Hodgkin's lymphoma, enrolling in phase II after specific conditions.I have been diagnosed with classical Hodgkin lymphoma.I have tested positive for HIV/AIDS.I have active brain or leptomeningeal metastases.My condition is in an advanced stage, specifically Ann Arbor Stage III or IV.I have been diagnosed with nodular lymphocyte-predominant Hodgkin's lymphoma.I have had a heart attack in the last 2 years.I have severe heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: < 60 years of age with advanced stage (HL) untreated
- Group 2: 60 years of age and older with HL (any stage) untreated
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Nivolumab is used to target which cancers?
"Metastatic ureter urothelial carcinoma is most frequently treated with Nivolumab. However, Nivolumab can also target other conditions such as metastatic hepatocellular carcinoma, malignant melanoma of skin, and adrenal medulla."
Answered by AI
How many medical facilities are participating in this research project?
"There are 10 sites where this study is being conducted. Some examples include Memorial Sloan Kettering Monmouth in Middletown, and Memorial Sloan Kettering Nassau in Uniondale. There are also other locations running the trial."
Answered by AI
How large is the test group for this experiment?
"Eighty-one patients who meet the inclusion criteria will be needed to complete this clinical trial. Patients can receive treatment from multiple sites, such as Memorial Sloan Kettering Monmouth in Middletown, New jersey and Memorial Sloan Kettering Westchester in Harrison, New york."
Answered by AI
Could you please list other investigations that have used Nivolumab?
"There are 1145 Nivolumab studies currently underway, with 213 of them being in the third and final stage. The many trials for this treatment are based out of Candiolo, TO, but there are 64677 locations running them."
Answered by AI
Has this type of research been done before?
"Alfacell's 1997 Nivolumab clinical trial, which involved 300 patients and completed Phase 3 drug approval, was the first of its kind. As of now, 1145 active trials are being conducted in 2943 cities across 71 countries. Of these ongoing studies, 1012 have already been completed."
Answered by AI
Are researchers looking for more test subjects?
"The answer is affirmative, this particular clinical trial is still looking for patients. The original posting was on 1/25/2017 and the most recent edit was on 2/16/2022. The ideal total number of participants is 81 people, who will be drawn from 10 different locations."
Answered by AI
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