Study on the Effectiveness and Safety of Tisotumab Vedotin for Patients with Solid Tumors

Inclusion Criteria

• Parts A, B, and C
  • Have relapsed, locally-advanced, or metastatic colorectal or pancreatic cancer, sqNSCLC, or HNSCC and are not candidates for standard therapy.
  • Have experienced disease progression after their most recent treatment.
  • For colorectal cancer (closed to enrollment): Must have had prior treatment with specific drugs and no more than 3 treatments for metastatic cancer.
  • For sqNSCLC (closed to enrollment): Must have squamous histology and prior treatment with platinum-based drugs and a checkpoint inhibitor, with no more than 3 treatments for metastatic cancer.
  • For exocrine pancreatic adenocarcinoma (closed to enrollment): Must have adenocarcinoma histology and prior treatment with specific regimens, with no more than 1 treatment for unresectable or metastatic cancer.
  • For HNSCC (closed to enrollment): Must have had prior treatment with platinum-based drugs and/or a checkpoint inhibitor, with no more than 3 treatments for recurrent or metastatic cancer.
• Part E
  • For HNSCC: Must have experienced disease progression after their most recent treatment, with no more than 1 or 2 treatments for recurrent/metastatic cancer, including a platinum-based regimen and a PD-(L)1 inhibitor.
• Parts D, F, and G
  • Part D is closed to enrollment. Parts F and G will enroll only participants with HNSCC.
  • For HNSCC: Must not have had previous systemic therapy for recurrent or metastatic disease.
  • Part D only
    • For NSCLC: Must have squamous cell NSCLC and no previous systemic therapy for metastatic disease or recent lung radiation over 30 Gy.
    • Must have PD-L1 biomarker expression available.
  • Part F only
    • Must have CPS ≥1 by local PD-L1 test and provide a tissue sample for PD-L1 testing.
  • Part G only
    • Non-EU: No CPS requirement for tisotumab vedotin with pembrolizumab and carboplatin.
    • EU: Must have CPS ≥1 by local PD-L1 test and provide a tissue sample for PD-L1 testing.
• Must have measurable disease by standard criteria.
• Must have a performance status score of 0 or 1.

Exclusion Criteria

• Have primary neuroendocrine or sarcomatoid tumors. For HNSCC, cannot have a primary site in the nasopharynx or salivary gland.
• Have active bleeding conditions.
• Have active eye surface disease (cataracts are not considered active for this study).
• Have another past or current cancer besides the one being studied.
• Have uncontrolled tumor-related pain.
• Have inflammatory lung disease requiring steroids or long-term oxygen.
• Have significant nerve damage (Grade 2 or higher).
• Have active brain metastasis.
• Have ongoing significant side effects from previous treatments.
• Parts D, F, and G Only: Cannot have had prior therapy with certain immune checkpoint inhibitors.