Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors

Inclusion Criteria:

   - Parts A, B, and C

      - Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer,
      sqNSCLC, or SCCHN participants who are not candidates for standard therapy.

      - All participants must have experienced disease progression on or after their most
      recent systemic therapy.

      - Colorectal cancer (closed to enrollment): participants must have received prior
      therapy with each of following agents, if eligible: a fluoropyrimidine,
      oxaliplatin, irinotecan, and/or bevacizumab. Participants should have received no
      more than 3 systemic regimens in the metastatic setting.

      - sqNSCLC (closed to enrollment): Participants with NSCLC must have predominant
      squamous histology. Participants must have received prior therapy with a
      platinum-based treatment and a checkpoint inhibitor (CPI), if eligible.
      Participants should have received no more than 3 lines of systemic therapy in the
      metastatic setting.

         - Participants eligible for a tyrosine kinase inhibitor should have received
         such therapy. These participants should have received no more than 4 lines
         of systemic therapy in the metastatic setting.

      - Exocrine pancreatic adenocarcinoma (closed to enrollment): Participants with
      exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma
      histology. Participants must have received prior therapy with a gemcitabine-based
      or 5FU-based regimen, if eligible, and should have received no more than 1
      systemic regimen in the unresectable or metastatic setting.

      - SCCHN (closed to enrollment): Participants with SCCHN in Part C must have
      received prior therapy with a platinum-based regimen and/or a checkpoint
      inhibitor (CPI), if eligible, and must have experienced disease progression
      following such therapy. Participants should have received no more than 3 systemic
      lines of therapy in the recurrent or metastatic setting.

   - Part E

      - Participants with SCCHN must have experienced disease progression on or after
      their most recent systemic therapy. Participants should have received no more
      than 1 or 2 systemic lines of therapy in the recurrent/metastatic setting as
      specified below. Participants must have received a platinum-based regimen and a
      PD-(L)1 inhibitor.

   - Parts D, F, and G

      - Part D is closed to enrollment. Part F and Part G will enroll only participants
      with SCCHN.

      - Participants with SCCHN must have received no previous systemic therapy in the
      recurrent or metastatic disease setting.

      - Part D only

         - Participants with NSCLC must have histologically or cytologically documented
         squamous cell NSCLC and must have received no previous systemic therapy for
         metastatic disease or radiation therapy to the lung that is > 30 Gy within 6
         months of the first dose of study treatment.

         - PD-L1 biomarker expression as determined by a PD-L1 IHC assay should be
         available

      - Part F only

         - Participants must have CPS ≥1 by local PD-L1 IHC assay to be eligible for
         enrollment. Participants must be able to submit a tissue sample for
         retrospective PD-L1 testing. Tissue may be fresh biopsy or archival,
         collected within 2 years of Cycle 1 Day 1.

      - Part G only

         - Non-EU eligibility criteria: No CPS requirement for the cohort evaluating
         tisotumab vedotin in combination with pembrolizumab and carboplatin.

         - EU-specific eligibility criteria: Participants must have a CPS ≥1 by local
         PD-L1 IHC assay.

         - Participants must be able to submit a tissue sample for retrospective PD-L1
         testing. Tissue may be fresh biopsy or archival, collected within 2 years of
         Cycle 1 Day 1.

   - Baseline measurable disease as measured by RECIST v1. 1.

   - Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Exclusion Criteria:

   - Participants with primary neuroendocrine or sarcomatoid histologies. For SCCHN,
   participants may not have a primary site of nasopharynx or salivary gland.

   - Active bleeding conditions

   - Ocular surface disease at the time of enrollment (Note: cataract is not considered
   active ocular surface disease for this protocol)

   - Other cancer: known past or current malignancy other than inclusion diagnosis.

   - Uncontrolled tumor-related pain

   - Inflammatory lung disease. Participants with pulmonary disease are allowed if systemic
   steroids and long-term oxygen are not required

   - Peripheral neuropathy greater than or equal to Grade 2

   - Active brain metastasis

   - Part D, F, and G Only: Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2
   agent or with an agent directed to another stimulatory or co-inhibitory T-cell
   receptor.