AzTrials
AzTrials

Hodgkin LymphomaPhase 1/2NCT03033914

A(B)VD Followed by Nivolumab as Frontline Therapy for Higher Risk Patients With Classical Hodgkin Lymphoma (HL)

A Phase 1/2 study testing doxorubicin, Bleomycin and vinblastine in people with Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 10 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The aim of this study is to improve the chance of cure for people with higher risk Hodgkin lymphoma. The purpose of the Phase I study is to test any good and bad effects of the study drug called Nivolumab when combined with ABVD for the front-line treatment of HL.The purpose of this Phase II study is to test whether… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
doxorubicin, Bleomycin and vinblastine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
10 sitesin 2 countries
Study dates
25 Jan 2017to Jan 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort A overview: Patients age less than 60 with untreated stage III or IV classical Hodgkin lymphoma will be eligible for cohort A. In phase I, patients could enroll onto cohort A if they had have a baseline IPS ≥3 OR if their PET scan after 2 cycles of ABVD is positive (Deauville 4 or 5). Enrollment onto phase I has now ceased and enrollment will begin for phase II.
  • In phase II, patients less than 60 years of age with stage III or IV HL are eligible. MSK patients may enroll anytime within the first 2 cycles of ABVD Non-MSK patients must enroll after positive PET-2 scan.
  • Cohort B overview: Patients 60 or older with untreated classical Hodgkin lymphoma (regardless of stage) will be eligible for cohort B.
  • 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
Show all 17Show fewer
  • 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)

Who cannot join

  • Subjects with active brain metastases or leptomeningeal metastases.
  • Subjects with nodular lymphocyte-predominant HL
  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Subjects with a condition requiring systemic treatment with systemic corticosteroids (equivalent of >10mg/day of prednisone). Patients may receive steroid therapy if steroids are tapered down to 10mg or less by 4 weeks after initiating A(B)VD to control lymphoma-related symptoms.
Show all 15Show fewer
  • Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
  • A left-ventricular ejection fraction < 50%
  • Myocardial infarction within 2 years of randomization
  • New York Heart Association (NYHA) Class III or IV heart failure
  • Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Any positive test for hepatitis B virus or hepatitis C virus indicating acute infection.
  • Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • History of severe hypersensitivity reaction to any monoclonal antibody.
  • Adjusted DLCO <60% (if unadjusted DLCO is >/=60% then there is no need to calculate adjusted

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States9 sites

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

Canada1 site

  • BC Cancer (Data Collection Only)

    Vancouver, V5Z4E6

Other trials in Canada

About this study

Official title: Phase I/II of Nivolumab and A(B)VD in the Front-line Setting for High Risk Hodgkin Lymphoma

The aim of this study is to improve the chance of cure for people with higher risk Hodgkin lymphoma. The purpose of the Phase I study is to test any good and bad effects of the study drug called Nivolumab when combined with ABVD for the front-line treatment of HL.The purpose of this Phase II study is to test whether including nivolumab in treatment for untreated Hodgkin lymphoma can improve the chance of cure for patients with abnormal PET scans after 2 cycles of ABVD.

Read the detailed description

The phase II portion of cohort A will enroll patients with untreated stage III or IV Hodgkin lymphoma. All patients will begin with 2 cycles of ABVD as standard of care treatment. A PET scan will be performed after 2 cycles of ABVD. Enrollment at MSK may occur at any point during the first two cycles of ABVD treatment. Enrollment at non-MSK locations will occur after the PET scan is performed. MSK patients 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) on-study. Non-MSK patients with a PET-negative response are not eligible for this study. Patients with a PET-positive response (Deauville 4 or 5) will proceed with 4 cycles of AVD plus nivolumab on-study. Non-MSK patients must have a PET-positive response to enroll on this study

Being tested
doxorubicin, Bleomycin, vinblastine, dacarbazine, Nivolumab
Keywords
Nivolumab, adriamycin, bleomycin, vinblastine, dacarbazine, 16-1536
Medical subject headings
Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • doxorubicinDrug

    Doxorubicin: 25 mg/m^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle

  • BleomycinDrug

    Bleomycin: 10 units/m^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle

  • vinblastineDrug

    Vinblastine: 6 mg/m^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle

  • dacarbazineDrug

    Dacarbazine (DTIC): 375 mg/m^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle.

  • NivolumabDrug

    nivolumab 240mg q14 days

Study groups in NCT03033914
Study groupRoleWhat they receive
< 60 years of age with advanced stage (HL) untreatedExperimentalThe 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).
Receives: Drug: doxorubicin; Drug: Bleomycin; Drug: vinblastine; Drug: dacarbazine; Drug: Nivolumab
60 years of age and older with HL (any stage) untreatedExperimentalThe 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.
Receives: Drug: doxorubicin; Drug: vinblastine; Drug: dacarbazine; Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of patients who have dose limiting toxicity

    For this objective, the standard 3+3 scheme will be used. Initially, 3 patients will enroll onto dose level 1. If no patients experience DLT, enrollment will proceed to the next dose level. If 1 DLT is observed, 3 additional patients will enroll onto dose level 1. If 1 or fewer patients out of 6 experience DLT, enrollment will proceed to the next dose level. If 2 or more DLTs are observed at a given dose level, the previous dose will be declared the MTD. Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. If CTCAE grading does not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, will be used.

    Measured: 2 years

  2. Phase II- progression free survival

    The updated response criteria entitled "The Lugano Classification" system will be applied to define complete response, partial response, and progression of disease in this study.

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2017 (estimated)
  2. Study start25 Jan 2017
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Cohort A will include patients less than 60 years of age with advanced stage (Stage III or IV) classical Hodgkin lymphoma (HL) who are at higer risk for relapse due to baseline international prognostic score (IPS) of 3-7 or positive PET scan after 2 cycles of ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) ("PET-2 positive").
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03033914
Sponsor's protocol ID
16-1536
Other IDs
CA209-447
Status last verified
Feb 2026
First submitted
25 Jan 2017
Last updated
17 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Torka P, Feldman T, Savage KJ, Ganesan N, Drill E, Hancock H, Davey T, Perez L, Capadona C, Subzwari S, Galasso N, Yang J, Post M, Boardman A, Caron P, David K, Epstein-Peterson Z, Falchi L, Ghione P, Hamlin P, Horwitz SM, Intlekofer AM, Johnson W, Kumar A, Lue J, Noy A, Owens C, Palomba ML, Salles GA, Steiner R, Stuver R, Vardhana S, Yahalom J, Dogan A, Zelenetz AD, Schoder H, Moskowitz AJ. Phase II Trial of Nivolumab Plus Doxorubicin, Vinblastine, Dacarbazine as Frontline Therapy in Older Adults With Hodgkin Lymphoma. J Clin Oncol. 2025 Mar 10;43(8):985-993. doi: 10.1200/JCO-24-01278. Epub 2024 Dec 11.

    PubMed 39661923

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing doxorubicin, Bleomycin and vinblastine in people with Hodgkin Lymphoma, run by Memorial Sloan Kettering Cancer Center at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of patients who have dose limiting toxicity (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03033914, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in