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

Conditions

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell of Head and Neck
• Colorectal Neoplasms
• Exocrine Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• tisotumab vedotin — DRUG
  Given into the vein (IV; intravenously)
• pembrolizumab — DRUG
  200mg or 400mg given by IV
• carboplatin — DRUG
  AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV
• cisplatin — DRUG
  100mg/m\^2 given by IV

Study Details

This trial will study tisotumab vedotin to find out whether it is an effective treatment alone or with other anticancer drugs for certain solid tumors and what side effects (unwanted effects) may occur. There are seven parts to this study. * In Part A, participants will receive tisotumab vedotin every 3 weeks (3-week cycles). * In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle. * In Part C, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part D, participants will be given treatment on Day 1 of every 3-week cycle. * Participants in Part D will get tisotumab vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin * In Part E, participants will receive tisotumab vedotin on Days 1 and 15 of every 4-week cycle. * In Part F, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part F will get tisotumab vedotin with pembrolizumab. * In Part G, participants will receive tisotumab vedotin on Days 1, 15, and 29 of every 6-week cycle. Participants in Part G will get tisotumab vedotin with pembrolizumab and carboplatin. The objectives of the study have been achieved. Therefore, the study will transition to a long-term extension phase (LTEP). * In LTEP, participants still receiving clinical benefit based on the investigator's assessment and remaining on treatment may continue receiving treatment. * Participants will still receive tisotumab vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin

Key Dates

Start date

Jun 25, 2018

Status verified

Apr 2026

Primary completion

Mar 20, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

350 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: Tisotumab Vedotin - Q3W Schedule
  Tisotumab Vedotin on Day 1 of every 21-day cycle in participants with various solid tumors in 2L+
• Experimental: Part B: Tisotumab Vedotin - 3Q4W Schedule
  Tisotumab Vedotin on Days 1, 8, and 15 of 28-day cycle in participants with various solid tumors in 2L+
• Experimental: Part C: Tisotumab Vedotin - 2Q4W Schedule
  Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC or sqNSCLC in 2L+
• Experimental: Part D: Tisotumab Vedotin Combination Therapy - Q3W Schedule
  Tisotumab Vedotin + pembrolizumab + (carboplatin or cisplatin). Given on Day 1 of every 21-day cycle in participants with various solid tumors in 1L HNSCC or sqNSCLC
• Experimental: Part E: Tisotumab Vedotin - 2Q4W Schedule
  Tisotumab Vedotin on Days 1 and 15 of every 28-day cycle in participants with HNSCC in the second- or third-line setting
• Experimental: Part F: Tisotumab Vedotin Combination Therapy - Q2W Schedule
  Tisotumab Vedotin + pembrolizumab. Tisotumab Vedotin given on Days 1, 15, and 29 of every 6-week cycle. Pembrolizumab given on Day 1 of every 6-week cycle in participants with HNSCC in the first line setting
• Experimental: Part G: Tisotumab Vedotin Combination Therapy - Q2W Schedule
  Tisotumab Vedotin + pembrolizumab + carboplatin. Tisotumab Vedotin and carboplatin given on Days 1, 15, and 29 of every 6-week cycle. Pembrolizumab given on Day 1 of every 6-week cycle in participants with HNSCC in the first line setting

Primary Outcome Measure

Confirmed Objective Response Rate (ORR) (Parts A, B, C, D, E, F, and G) [ Time Frame: Up to approximately 3 years ]

Locations (124)

Find similar trials in Encinitas, CA

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