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Efficacy and Safety Study of ...

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

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2027-03-31

Brief Summary

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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

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Detailed Description

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The primary goal of this trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated with single agent tisotumab vedotin or tisotumab vedotin in combination with other anticancer agents. Patients who meet eligibility criteria will be enrolled into cohorts based on tumor type. Tumor types to be evaluated include colorectal cancer, squamous non-small cell lung cancer (sqNSCLC), exocrine pancreatic adenocarcinoma, and head and neck squamous cell carcinoma (HNSCC).

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Tisotumab Vedotin - Q3W Schedule

Tisotumab Vedotin on Day 1 of every 21-day cycle in participants with various solid tumors in 2L+

Group Type EXPERIMENTAL

tisotumab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenously)

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+

Group Type EXPERIMENTAL

tisotumab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenously)

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+

Group Type EXPERIMENTAL

tisotumab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenously)

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

Group Type EXPERIMENTAL

tisotumab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenously)

pembrolizumab

Intervention Type DRUG

200mg or 400mg given by IV

carboplatin

Intervention Type DRUG

AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV

cisplatin

Intervention Type DRUG

100mg/m\^2 given by IV

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

Group Type EXPERIMENTAL

tisotumab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenously)

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

Group Type EXPERIMENTAL

tisotumab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenously)

pembrolizumab

Intervention Type DRUG

200mg or 400mg given by IV

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

Group Type EXPERIMENTAL

tisotumab vedotin

Intervention Type DRUG

Given into the vein (IV; intravenously)

pembrolizumab

Intervention Type DRUG

200mg or 400mg given by IV

carboplatin

Intervention Type DRUG

AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV

Interventions

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tisotumab vedotin

Given into the vein (IV; intravenously)

Intervention Type DRUG

pembrolizumab

200mg or 400mg given by IV

Intervention Type DRUG

carboplatin

AUC 5mg/mL per minute or AUC 3.3mg/mL per minute given by IV

Intervention Type DRUG

cisplatin

100mg/m\^2 given by IV

Intervention Type DRUG

Other Intervention Names

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TIVDAK KEYTRUDA®

Eligibility Criteria

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Inclusion Criteria

* Parts A, B, and C

* Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, sqNSCLC, or HNSCC 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.
* HNSCC (closed to enrollment): Participants with HNSCC 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

* Part E is closed to enrollment.
* Participants with HNSCC 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 and F are closed to enrollment. Part G will enroll only participants with HNSCC.
* Participants with HNSCC 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

* Part G cohort was not opened.
* 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 HNSCC, participants may not have a primary site of nasopharynx or salivary gland.
* Active bleeding conditions
* Clinically significant cardiac disease including stable angina, acute myocardial infraction 6 months prior to screening
* 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
* Ongoing clinically significant toxicity associated with prior treatment (including radiotherapy or surgery).
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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UCSD Medical Center - Encinitas

Encinitas, California, United States

Site Status

UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

La Jolla, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

UCSD Koman Family Outpatient Pavilion

La Jolla, California, United States

Site Status

UC San Diego/Moores Cancer Center

La Jolla, California, United States

Site Status

UCSD Shiley Eye Institute

La Jolla, California, United States

Site Status

University of California Davis Medical Center

Sacramento, California, United States

Site Status

University of California, Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

UC San Diego Medical Center- Hillcrest

San Diego, California, United States

Site Status

UC San Diego Health - Rancho Bernardo

San Diego, California, United States

Site Status

Stanford Cancer Center South Bay

San Jose, California, United States

Site Status

UCSD Medical Center - Vista

Vista, California, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Eye Center of Northern Colorado

Fort Collins, Colorado, United States

Site Status

Cancer Care & Hematology - Fort Collins

Fort Collins, Colorado, United States

Site Status

Eye Center of Northern Colorado

Fort Collins, Colorado, United States

Site Status

Cancer Care & Hematology - Greeley

Greeley, Colorado, United States

Site Status

Cancer Care & Hematology - Loveland

Loveland, Colorado, United States

Site Status

Simlow Cancer Hospitalat Yale-New Haven

New Haven, Connecticut, United States

Site Status

Yale-New Haven Hospital- Yale Cancer Center

New Haven, Connecticut, United States

Site Status

C/O Thomas Ferenez.RPh,BCOP,Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Family Focus Eye Care - Gainesville

Gainesville, Florida, United States

Site Status

UF Health Davis Cancer Pavilion and Shands Med Plaza

Gainesville, Florida, United States

Site Status

UF Health Shands Cancer Hospital

Gainesville, Florida, United States

Site Status

UF Health Shands Hospital

Gainesville, Florida, United States

Site Status

Family Focus Eye Care - Lake City

Lake City, Florida, United States

Site Status

Moffitt Cancer Center McKinley Hospital

Tampa, Florida, United States

Site Status

Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Richard M Schulze Family Foundation Outpatient Center at McKinley Campus

Tampa, Florida, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Investigational Drug Service, Emory University Clinic

Atlanta, Georgia, United States

Site Status

The Emory Clinic

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Site Status

Northwestern Medical Group

Chicago, Illinois, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

UChicago Medicine - River East

Chicago, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Site Status

Northwestern Medicine Kishwaukee Hospital

DeKalb, Illinois, United States

Site Status

Primary Healthcare Associates

Flossmoor, Illinois, United States

Site Status

UChicago Medicine at Ingalls - Flossmoor

Flossmoor, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status

Northwestern Medicine Delnor Hospital

Geneva, Illinois, United States

Site Status

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Primary Healthcare Associates

Harvey, Illinois, United States

Site Status

UChicago Medicine Ingalls Memorial

Harvey, Illinois, United States

Site Status

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, United States

Site Status

The University of Chicago Medicine Center for Advanced Care Orland Park

Orland Park, Illinois, United States

Site Status

Primary Healthcare Associates

Tinley Park, Illinois, United States

Site Status

UChicago Medicine at Ingalls - Tinley Park

Tinley Park, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status

Community Health Network, Inc.

Indianapolis, Indiana, United States

Site Status

Community Health Network, Inc.

Indianapolis, Indiana, United States

Site Status

Community Health Network, Inc.

Indianapolis, Indiana, United States

Site Status

Community Health Network, Inc.

Indianapolis, Indiana, United States

Site Status

The University of Kansas Cancer Center ,Investigational Drug Services

Fairway, Kansas, United States

Site Status

The University of Kansas Clinical Research Center

Fairway, Kansas, United States

Site Status