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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age2 Years to 21 Years
• SexAll
• Healthy volunteersNo

You may be able to join 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
• 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

You cannot join if

• 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
• 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

nivolumab. A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1, PCD-1) with immune checkpoint inhibitory and antineoplastic activities. Upon administration, nivolumab binds to and blocks the activation of PD-1, an immunoglobulin superfamily (IgSF) transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), which is overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on antigen-presenting cells (APCs). This results in the activation of T cells and cell-mediated immune responses against tumor cells. Activated PD-1 negatively regulates T-cell activation and plays a key role in tumor evasion from host immunity. NCI Drug Dictionary

Treatments listed in the registry

• Nivolumab (Drug): Given by IV
• Doxorubicin Hydrochloride (Drug): Given by IV
• Vinblastine (Drug): Given by IV
• Dacarbazine (Drug): Given by IV

Na · Single Group · masking: None

Main goals

• Safety and Adverse Events (AEs) (Through study completion; an average of 1 year)

Planned enrollment: 15 (estimated).

• UT MD Anderson, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07551583
• NCI Drug Dictionary: C68814

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 30, 2026. Public record; not medical advice.