Previous treatment with brentuximab vedotin will be allowed if it was done 6 months prior to enrollment and was not refractory to or had progressive disease (PD) on brentuximab vedotin (BV)
Pregnancy or breast-feeding women; breastfeeding should be discontinued if the mother is treated with brentuximab vedotin
For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
Brentuximab vedotin naive OR had at least stable disease by Lugano Classification to prior brentuximab vedotin treatment
Refractory to prior brentuximab vedotin (i.e. progression while on treatment)
History of prior >= grade 3 hypersensitivity to either brentuximab vedotin or nivolumab
Brentuximab vedotin
Prior treatment with at least 2 lines of therapy for HL including brentuximab vedotin; in those patients who cannot receive brentuximab vedotin, treatment with 2 prior therapeutic regimens is sufficient
Prior treatment with brentuximab vedotin is allowed provided the patient did not progress on BV or within 30 days of last dose of BV; patients must be at least 3 months from the last dose of BV
Refractory to prior therapy with brentuximab vedotin (evidence of progression within 30 days of the last dose)
Previous exposure to brentuximab vedotin (BV)
Prior brentuximab vedotin is allowed in the dose-finding portion of the study (dose-finding cohort); in the expansion cohort, patients cannot be refractory to BV (defined as developing progressive disease while on treatment or progressed within 3 months of finished last dose of brentuximab vedotin)
Failed >= 2 prior systemic therapies\r\n* NOTE: For systemic anaplastic large cell lymphoma (ALCL) prior systemic therapy must also include progression on brentuximab vedotin
Known hypersensitivity to brentuximab vedotin components
Histologically confirmed CD30-positive (defined in this study as >= 1% expression) MF (including large cell transformation variant) or SS who have either:\r\n* Received prior systemic therapy (for whom commercial supply of brentuximab vedotin is available) OR\r\n* Not received prior systemic therapy (who will receive brentuximab vedotin free of charge)
Previous brentuximab treatment
Prior brentuximab vedotin is allowed provided that patients were not refractory (defined as developing progressive disease while on treatment or progressed within 3 months of finished last dose of brentuximab vedotin)
Patient has hypersensitivity to brentuximab vedotin
Refractory to prior brentuximab vedotin (defined as developing progressive disease while on treatment or progressed within 3 month of finished last dose of brentuximab vedotin)
Patients who have received prior histone deacetylase (HDAC) inhibitors, or brentuximab vedotin, may be permitted to enter the study unless they have received an HDAC inhibitor or brentuximab within the last 6 months
Eligible to receive standard brentuximab vedotin for relapsed Hodgkin lymphoma
Patients with prior receipt of brentuximab vedotin
Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients in the nivolumab/brentuximab cohorts ONLY (D, E, F, Y) may have received prior ipilimumab
Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
RANDOMIZED PHASE II (ARMS K AND L): Patients may have received prior brentuximab vedotin, but must not have received brentuximab vedotin within 6 months prior to registration, and must not have relapsed within 6 months of receiving previous brentuximab vedotin; patients may not have received prior nivolumab or PD1/PDL1 axis agents; patients may not have received prior ipilimumab
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
Relapsed or refractory CD30+ lymphoma that has either achieved < PR to brentuximab vedotin (minimum of 2 cycles), progressed while receiving brentuximab vedotin, or progressed within 6 months of the last dose of brentuximab vedotin
Resolution of all non-hematologic brentuximab vedotin-related adverse events (AEs) to < grade 2
Intolerance to brentuximab vedotin
Patients receiving chronic treatment with systemic steroids; however, patients can receive up to 10 days of steroid therapy prior to starting treatment with brentuximab vedotin (BV)+ doxorubicin, vinblastine, dacarbazine (AVD)
May have received either brentuximab vedotin or lenalidomide/immunomodulatory imide drugs (IMiD) without dose modification/delay due to toxicity\r\n* IMiDs defined as thalidomide analogues
If received prior brentuximab vedotin or lenalidomide, must be able to tolerate the dose level to which the participant will be enrolled to
Allergic reaction/hypersensitivity to lenalidomide or history of anaphylactic shock to brentuximab vedotin in the past
Previously untreated with either chemotherapy, radiation therapy or either brentuximab vedotin or nivolumab, or another check point inhibitor
Allergy to brentuximab vedotin and/or nivolumab
Prior treatment with brentuximab vedotin (BV)
Known allergy to bevacizumab or brentuximab vedotin or any of its excipients
Relapsed or refractory disease after standard therapy including brentuximab vedotin (Adcetris®).
Previously treated with brentuximab vedotin, immune-oncology agents, or received an allogeneic or autologous stem cell transplant
Classical Hodgkin lymphoma\r\n* Relapsed or refractory de novo classical Hodgkin lymphoma having failed standard first-line therapy; and\r\n* May have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve but is ineligible or unable to receive brentuximab vedotin; and\r\n* May have failed to achieve a response to, progressed after, or is ineligible for autologous stem cell transplant (auto-SCT)
Subjects may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B & C - enrolment closed)
Prior treatment with brentuximab vedotin is allowed provided the patient did not progress on BV or within 30 days of last dose of BV; patients must be at least 3 months from the last dose of BV
Refractory to prior therapy with brentuximab vedotin (evidence of progression within 30 days of the last dose)
Male subject agrees to use an acceptable method for contraception during the entire study treatment period and through 6 months after the last dose of brentuximab vedotin
Previous primary progression or grade 3 toxicity on treatment with brentuximab vedotin
Participant may have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve
If female of childbearing age, negative serum pregnancy test within 7 days prior to the first dose of brentuximab vedotin in this study
Prior treatment with brentuximab vedotin and bendamustine in combination; may have received prior therapy with brentuximab vedotin or bendamustine separately
Received either brentuximab vedotin or bendamustine within 3 months of receiving their first dose of protocol based therapy
If brentuximab vedotin or bendamustine was previously received, had disease progression during the first 3 cycles of either brentuximab vedotin or bendamustine
Known hypersensitivity to brentuximab vedotin, bendamustine, or mannitol
Prior to day 1 of brentuximab vedotin, please verify the patient does not meet the criteria below:\r\n* Symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
Previous receipt of brentuximab vedotin Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Previous treatment with brentuximab vedotin
Prior use of brentuximab vedotin
Must have had prior treatment with brentuximab vedotin or not a candidate for treatment with brentuximab vedotin
Prior administration of brentuximab vedotin
Previous treatment with brentuximab vedotin or bendamustine.
No prior brentuximab vedotin
Patient has hypersensitivity to brentuximab vedotin
Patient has received other investigational drugs within 14 days before treatment of treatment with brentuximab vedotin
In addition to the inclusion/exclusion criteria outlined, to be eligible for treatment with the higher 2.4 mg/kg dose of brentuximab vedotin in the new cohort of 20 additional patients, best response after 2 cycles of brentuximab vedotin administered at the 1.8 mg/kg dose, must be partial remission (PR) or stable disease (SD) as determined by radiographic imaging
Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
Previous treatment with brentuximab vedotin.
Prior use of brentuximab vedotin for GVHD is not allowed; prior use of brentuximab vedotin for the treatment of malignancy is allowed
Patient must not have had prior exposure to brentuximab vedotin
Prior use of brentuximab vedotin for GVHD is not allowed; prior use of brentuximab vedotin for the treatment of malignancy, i.e. Hodgkin lymphoma, anaplastic large cell lymphoma, etc. is allowed