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Hodgkin LymphomaPhase 2NCT07551583

Phase II Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL

A Phase 2 study testing Nivolumab, Doxorubicin Hydrochloride and Vinblastine in people with Hodgkin Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical research study is to learn if nivolumab plus AVD (doxorubicin, vinblastine, and dacarbazine) can help to control newly diagnosed early-stage non-bulky cHL in pediatric, adolescent, and young adult patients. The safety of this drug combination will also be studied. Read more about this study

Who is it for?
Ages 2 to 21 years
Conditions the study is for
Hodgkin Lymphoma
What is being tested?
Nivolumab, Doxorubicin Hydrochloride and Vinblastine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
19 Aug 2026to 31 Dec 2032
Phase
Phase 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 2 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age ≥ 2 year to 21 years
  • Newly diagnosed early-stage (I/II) non-bulky (<10cm) classical Hodgkin lymphoma
  • Baseline ejection fraction must be > 40%
  • Adequate hepatic function (direct bilirubin < 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or lymphoma involvement, and AST and/or ALT < 3x ULN unless considered due to lymphoma involvement, in which case direct bilirubin < 3x ULN or AST and/or ALT < 5x ULN will be considered eligible)
  • Adequate renal function (creatinine clearance ≥ 30 mL/min) unless related to disease
  • ECOG performance status ≤2 (Karnofsky ≥60%,) (See Appendices)
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  • In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy (whichever is shorter). Steroids for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better as classified by PI
  • Unless surgically or biologically sterile: Women of childbearing potential must agree to adequate methods of contraception during the study and at least 3 months for males, and 6 months for females, after the last treatment
  • The effects of this combination of chemotherapy on the developing human fetus are unknown. For this reason, these agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
  • History of bilateral tubal ligation or another surgical sterilization procedure.
  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document as detailed below and if minor, getting parental/guardian consent

Who cannot join

  • 11) Patients who have received prior systemic therapy for the lymphoma with the exclusion of steroids for inflammatory conditions (e.g. asthma) or greater than 72 hours of emergent steroids (e.g. symptomatic mediastinal mass)
  • Patients who weigh less than 10kg
  • Any severe allergy to any of the drugs (Nivo-AVD)
  • Patients with any concurrent uncontrolled medical condition, infection, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment
  • Patients who are receiving any other cancer directed investigational agents; The use of other chemotherapeutic agents or anti-lymphoma agents is not permitted during study
  • Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years. Subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
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  • Current or prior use of immunosuppressive medication within 14 days prior to the first dose of nivolumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection).
  • The use of stable systemic steroid doses less than or equal to 20 mg of prednisone daily are permitted for medical conditions needing systemic steroids.
  • Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication
  • 12) The use of strong inhibitors or inducers of CYP1A2 (dacarbazine interaction) or CYP3A4 (doxorubicin, vinblastine interactions) should be avoided. Multiple CYP3A4 interacting agents of moderate or strong effect in the HIV+ patients should not be used. This includes most HIV protease inhibitors. 13) Known active HIV and hepatitis B and hepatitis C (unless see below points (a)(b)). Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients with prior hepatitis B and hepatitis C with are undetectable viral load are eligible for this trial.
  • 14) For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • 7) Patients with psychiatric illness/social situations that would limit compliance with study requirements 8) Patients with a concurrent active malignancy under treatment 9) Pregnant women are excluded from this study because these agents have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated on protocol

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David McCall, MD contact

(713) 792-6604

dmccall1@mdanderson.org

United States1 site, 1 recruiting

  • UT MD Anderson

    Houston, Texas, 77030

    David McCall, MD, 713-792-6604, dmccall1@mdanderson.org

    David McCall, MD

    Recruiting

Other trials in United States

About this study

Official title: A Phase II Single Arm Study to Evaluate Safety and Preliminary Efficacy of Nivolumab Plus AVD in Pediatric, Adolescent, And Young Adult Patients With Newly Diagnosed Early-stage Non-bulky Classical Hodgkin Lymphoma

The goal of this clinical research study is to learn if nivolumab plus AVD (doxorubicin, vinblastine, and dacarbazine) can help to control newly diagnosed early-stage non-bulky cHL in pediatric, adolescent, and young adult patients.

The safety of this drug combination will also be studied.

Read the detailed description

Primary Objectives:

Patients receive nivolumab intravenously (IV) over 30 minutes, doxorubicin IV over 15 minutes, vinblastine IV over 15 minutes, and dacarbazine IV over 60 minutes on days 1 and 15 of each cycle.

  1. To characterize the clinical preliminary efficacy of nivolumab plus AVD in pediatric, adolescent, and young adult patients with newly diagnosed early-stage non-bulky classical Hodgkin lymphoma based upon the overall response rate (ORR).

II. To assess the safety of nivolumab plus AVD in pediatric, adolescent, and young adult patients with newly diagnosed early-stage non-bulky classical Hodgkin lymphoma.

III. To summarize the incidence, prevalence, and severity of adverse drug reactions according to Common Terminology Criteria for Adverse Events (CTCAE) National Cancer Institute (NCI) CTCAE version 5.0.

Secondary Objective:

  1. To assess the efficacy and duration of response (DOR), relapse-free survival (RFS), and overall survival (OS) of patients with newly diagnosed early-stage non-bulky classical Hodgkin lymphoma treated with this combination.

Outline:

Patients receive nivolumab intravenously (IV) over 30 minutes, doxorubicin IV over 15 minutes, vinblastine IV over 15 minutes, and dacarbazine IV over 60 minutes on days 1 and 15 of each cycle.

Cycles repeat every 28 days for 2 cycles. After cycle 2, patients with complete response and Deauville score of 1, 2, or 3 receive 2 additional cycles of treatment (cycles 3 and 4). Patients with partial response or stable disease (Deauville score of 4 or 5) receive 4 additional cycles of treatment (cycles 3-6). Patient with progressive disease, no response, or unacceptable toxicity will come off study.

Being tested
Nivolumab, Doxorubicin Hydrochloride, Vinblastine, Dacarbazine
Medical subject headings
Hodgkin Disease

What participants receive

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

  • NivolumabDrug

    Also called Opdivo

    Given by IV

  • Doxorubicin HydrochlorideDrug

    Also called Adriamycin

    Given by IV

  • VinblastineDrug

    Also called Velban

    Given by IV

  • DacarbazineDrug

    Also called DTIC

    Given by IV

Study groups in NCT07551583
Study groupRoleWhat they receive
Phase II: Treatment with Nivolumab + AVDExperimentalTreatment will be administered on an inpatient and outpatient basis. Participants will be admitted for day 1 of chemotherapy for cycle 1 and evaluated for 1 or more days following chemotherapy as needed for tumor lysis or supportive care needs as directed by standard of care.
Receives: Drug: Nivolumab; Drug: Doxorubicin Hydrochloride; Drug: Vinblastine; Drug: Dacarbazine

What is being measured

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

  1. Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 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 Apr 2026
  2. Study start19 Aug 2026
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2032 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07551583
Sponsor's protocol ID
2026-0119
Other IDs
NCI-2026-03212
Status last verified
Aug 2026
First submitted
21 Apr 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab, Doxorubicin Hydrochloride and Vinblastine in people with Hodgkin Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

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 16 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 phase mean?

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?

Contact David McCall, MD ((713) 792-6604, dmccall1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). 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 NCT07551583.

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 31 Aug 2026.

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