Phase 2 Study Of Nivolumab Plus AVD In Pediatric, Adolescent, And Young Adult Patients With CHL

May 18, 2026 updated by: M.D. Anderson Cancer Center

A Phase 2 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

I. 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:

I. 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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson
        • Contact:
        • Principal Investigator:
          • David McCall, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 2 year to 21 years
  2. Newly diagnosed early-stage (I/II) non-bulky (<10cm) classical Hodgkin lymphoma
  3. Baseline ejection fraction must be > 40%
  4. 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)
  5. Adequate renal function (creatinine clearance ≥ 30 mL/min) unless related to disease
  6. ECOG performance status ≤2 (Karnofsky ≥60%,) (See Appendices)
  7. 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
  8. 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

  9. 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.

  10. Ability to understand and the willingness to sign a written informed consent document as detailed below and if minor, getting parental/guardian consent

Exclusion Criteria:

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)

  1. Patients who weigh less than 10kg
  2. Any severe allergy to any of the drugs (Nivo-AVD)
  3. Patients with any concurrent uncontrolled medical condition, infection, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment
  4. 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
  5. 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

  6. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of nivolumab. The following are exceptions to this criterion:

    1. Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection).
    2. 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.
    3. 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

a. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase II: Treatment with Nivolumab + AVD
Treatment 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.
Drug: Nivolumab
Given by IV
Other Names:
  • Opdivo
Drug: Vinblastine
Given by IV
Other Names:
  • Velban
Drug: Doxorubicin Hydrochloride
Given by IV
Other Names:
  • Adriamycin
Drug: Dacarbazine
Given by IV
Other Names:
  • DTIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Adverse Events (AEs)
Time Frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: David McCall, MD, UT MD Anderson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0119
  • NCI-2026-03212 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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