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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
The following eligibility criteria applies to both cohort A and B except when stated otherwise: Histologic diagnosis of classical Hodgkin lymphoma, FDG-avid disease by FDG-PET/CT, Non-MSK patients ONLY: PET-2 positive disease (Cohort A only), Ann Arbor Stage III or IV disease (Cohort A only), WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 2 weeks prior to the start of study drug. Women who undergo fertility preservation within 2 weeks of beginning chemotherapy are expected to have false-positive pregnancy tests and therefore testing may be waived for these patients., WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. Women who undergo fertility preservation within 2 weeks of beginning chemotherapy are expected to have false-positive pregnancy tests and therefore testing may be waived for these patients., Reliable methods of birth control include a double barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, tubal ligation or total abstinence during the study, Women must not be breastfeeding, Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception (i.e. use of a condom during intercourse) for the duration of treatment with study drug plus 5 half-lives of study drug plus 90 days (duration of sperm turnover) for a total of 31 weeks posttreatment completion, 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), AST/ALT ≤ 3 x ULN (5x ULN for those with lymphoma involvement of the liver), Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Cohort B overview: Patients 60 or older with untreated classical Hodgkin lymphoma (regardless of stage) will be eligible for cohort B.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
No Placebo-Only Group

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 below
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I am 60 or older with untreated classical Hodgkin lymphoma.
Select...
My condition is in an advanced stage, specifically Ann Arbor Stage III or IV.
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I am under 60 with stage III or IV Hodgkin lymphoma, enrolling in phase II after specific conditions.
Select...
I am under 60 with stage III or IV Hodgkin lymphoma, untreated, and qualify for cohort A.
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I am 18 years old or older.
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My kidney function, measured by creatinine levels, is within the normal range.
Select...
I have been diagnosed with classical Hodgkin lymphoma.

Timeline

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

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 • 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%
Superior vena cava syndrome
1%
Cancer pain
1%
Syncope
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Neoplasm progression
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

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: < 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
~4800

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,920 Previous Clinical Trials
590,857 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,625 Previous Clinical Trials
4,118,932 Total Patients Enrolled
British Columbia Cancer AgencyOTHER
171 Previous Clinical Trials
90,432 Total Patients Enrolled

Media Library

Bleomycin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03033914 — Phase 1 & 2
Hodgkin's Lymphoma Research Study Groups: < 60 years of age with advanced stage (HL) untreated, 60 years of age and older with HL (any stage) untreated
Hodgkin's Lymphoma Clinical Trial 2023: Bleomycin Highlights & Side Effects. Trial Name: NCT03033914 — Phase 1 & 2
Bleomycin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03033914 — Phase 1 & 2

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
~17 spots leftby Jan 2026