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

NCT07551583 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2026-0119NCI-2026-03212
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (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

  Through study completion; an average of 1 year

Study Arms (1)

Phase II: Treatment with Nivolumab + AVD

EXPERIMENTAL

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; Drug: Doxorubicin Hydrochloride; Drug: Vinblastine; Drug: Dacarbazine

Interventions

Nivolumab DRUG

Given by IV

Also known as: Opdivo

Phase II: Treatment with Nivolumab + AVD

Doxorubicin Hydrochloride DRUG

Given by IV

Also known as: Adriamycin

Phase II: Treatment with Nivolumab + AVD

Vinblastine DRUG

Given by IV

Also known as: Velban

Phase II: Treatment with Nivolumab + AVD

Dacarbazine DRUG

Given by IV

Also known as: DTIC

Phase II: Treatment with Nivolumab + AVD

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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
• 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

You may not qualify if:

• 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
• 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
• \) 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.
• \) 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
• \) 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Nivolumab; Doxorubicin; Vinblastine; Dacarbazine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• David McCall, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David McCall, MD

CONTACT

(713) 792-6604; dmccall1@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)