BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

Allowed: BRAF v600-activating mutation

Must have received: standard antineoplastic therapy — appropriate for tumor type and stage

Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.

Must have received: targeted therapy — subjects with known activation mutations

Subjects with known activation mutations must have prior target therapy.

Must have received: anti-PD-1 therapy — Melanoma, Part A

Required prior therapies will include anti-programmed death-ligand 1 (PD-1) therapy either as monotherapy or as part of a combination regimen.

Must have received: BRAF inhibitor — Melanoma, Part A, BRAF V600-activating mutation

For subjects with a known BRAF V600-activating mutation combination targeted therapy will be required in addition to anti-PD-1/programmed death-ligand 1 (PD-L1) therapy.

Must have received: systemic therapy — TCL, Stage IB-IV

Stage IB-IV with failure of at least 1 systemic therapy.

Cannot have received: allo hematopoietic stem cell transplantation

No prior allo hematopoietic stem cell transplantation (HSCT)

Cannot have received: auto hematopoietic stem cell transplantation

Exception: allowed if >90 days since auto HSCT

>90 days since auto HSCT

Cannot have received: chemotherapy

Exception: allowed if >4 weeks since last dose

Chemotherapy or small molecule products within 4 weeks of first dose of BI-1808

Cannot have received: immunotherapy

Exception: allowed if >4 weeks since last dose

Immunotherapy within 4 weeks prior to the first dose of BI-1808

Cannot have received: radiotherapy

Exception: allowed if >2 weeks since last dose; 1-week washout permitted for palliative radiation (≤2 weeks of radiotherapy) for non-CNS disease

Radiotherapy within 2 weeks of first dose of BI-1808. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) for non-CNS disease.

Cannot have received: investigational agent

Exception: allowed if >4 weeks since last dose

has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study drug

Cannot have received: immunosuppressive therapy

Exception: allowed if >7 days prior to first dose

taking any other form of immunosuppressive therapy within 7 days prior the first dose of study drug