A Trial of Nivolumab + Brentuximab Vedotin for Children, Adolescents, and Young Adults with Relapsed/Refractory CD30+ classic Hodgkin Lymphoma after Failure of First-Line Therapy, followed by Brentuximab + Bendamustine for Participants with Suboptimal Response

About this Study

This study is being done to look at the response rate and tolerability of nivolumab + brentuximab vedotin in patients with relapsed/refractory CD30+ classic Hodgkin Lymphoma after failure of first-line therapy. The study will also look at the response rate and tolerability of brentuximab + bendamustine in patients with suboptimal response to nivolumab + brentuximab therapy on this study.

Sponsor Protocol ID:	CA209744
IRB Number:	2017-0165
Study Status: Study Status Actively Enrolling: The study is currently recruiting participants. Closed for Enrollment: The study is not currently recruiting participants.	Actively Enrolling
Study Type: Study Type Interventional: A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.	Observational
Study Phase: Study Phase Early Phase 1 Trials (formerly listed as Phase 0): Exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies). Phase 1 Trials: Trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants. Phase 2 Trials: Trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Phase 3 Trials: Trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants. Phase 4 Trials: Trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.	Phase 2
Online Start Date: Online Start Date The online start date is the day that this trial first appeared on the UMMC website, which is not necessarily the day that the trial first began at UMMC.	May 28, 2019

Eligibility Criteria

Minimum Age Age Requirement Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.	5 years old
Maximum Age Age Requirement Studies may have specific age requirements. Some may only accept participants over a specified age and/or under a specified age. Please read the study description and additional eligibility criteria for specific information.	30 years old
Biological Sex Biological Sex Requirement Indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.	Both Male and Female
Cancer Related? Cancer Related Some studies may be targeted to cancer-related treatments or research. Please read the study description and additional eligibility criteria for specific information.	Yes
Pediatric Related? Pediatric Related Some studies may be targeted to child-related treatments or research. Please read the study description and additional eligibility criteria for specific information.	Yes
Accepts Healthy Volunteers? Accepts Healthy Volunteers Indicates whether people who do not have the condition/disease being studied can participate in the clinical study. Healthy volunteers play an important role in research because they help define "normal" ranges. While they may receive no direct benefit, healthy volunteers choose to participate in clinical research because they want to help others and contribute to advancing science.	No

Inclusion Criteria

Signed Informed Consent Form.
Participants must have measurable disease, documented by pathological and radiographic criteria.
Males and Females, ages 5 to 30 years.
Women must not be breastfeeding.
Participants must have received first-line anti-cancer therapy that failed.
Participants must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy prior to signing consent.

Exclusion Criteria

Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). NOTE: Testing for HIV must be performed at sites where mandated locally.
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.
Participants who received more than one line of anti-cancer therapy or are treatment naive are not eligible.
Participants who have received a prior solid organ transplantation are not eligible.
Prior radiation therapy within 3 weeks, or chest radiation
Any concurrent anti-neoplastic therapy.
Any positive test for hepatitis B or C virus indicating acute or chronic infection, and/or detectable virus.
History of allergy or hypersensitivity to study drug components.
Participants with serious or uncontrolled medical disorders that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy, or
interfere with the interpretation of study results.
Prisoners or participants who are involuntarily incarcerated.
Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.