Trial purpose
Cancer treatment
Tumor type
Haematological
Age
12+
Clinical summary
Summary
This is a non-randomised, parallel assignment study that has three parts. Part A involves the anticancer drug Brentuximab vedotin and chemotherapy drugs doxorubicin, vinblastine, and dacarbazine (this combination is also known as A+AVD) being administered separately via intravenous infusion (IV) to participants with advanced stage classical Hodgkin lymphoma (cHL) during each treatment cycle. Participants in Part A will also be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment. Part B involves the anticancer drug Brentuximab vedotin, immunotherapy drug nivolumab, and chemotherapy drugs doxorubicin and dacarbazine (this combination is also known as AN+AD) being administered separately via IV to participants with Stage II bulky mediastinal disease and Stage III or IV cHL during each treatment cycle. Part C involves AN+AD being administered separately via IV in participants with Stage I or II cHL with non-bulky mediastinal disease during each treatment cycle.
Conditions
This trial is treating people with Hodgkin's Lymphoma
Eligibility
Exclusion
- Nodular lymphocyte predominant HL
- History of another malignancy within 3 years of the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk or metastasis or death. Participants with nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection
- Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 4 weeks of the first study drug dose
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Active cerebral/meningeal disease related to the underlying malignancy
- Any active Grade 3 or higher viral, bacterial, or fungal infection within two weeks of the first dose of study drug (Grade 3 defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03)
- Current therapy with other systemic anti-neoplastic or investigational agents
- Planned consolidative radiotherapy (Parts B and C only)
- Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity (Parts B and C only)
- Grade 3 or higher pulmonary disease unrelated to underlying malignancy
- Documented history of idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted
- History of a cerebral vascular event within 6 months of first dose of study drug
- Child-Pugh B or C hepatic impairment
- Grade 2 or higher peripheral sensory or motor neuropathy
- Participants with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment or as prophylaxis against GvHD
- Previous treatment with brentuximab vedotin
- Participants who are pregnant or breastfeeding
- Other serious condition that would impair the participant's ability to receive or tolerate the planned treatment and follow-up
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Seagen Inc.
Scientific Title
Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information