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Clinical Trial Details

Geo Regions

Category

Other or Multiple Cancer Types

Tisotumab vedotin

A Phase 1b/2 Open-Label Trial of Tisotumab Vedotin (HuMax®-TF-ADC) Monotherapy and in Combination With Other Agents in Subjects With Recurrent or Stage IVB Cervical Cancer
Phase 1 /2
NCT03786081

Active Not-enrolling

Globe
Locations

United States, Belgium, Czechia, Denmark, Ireland, Italy, Netherlands, Spain, Turkey, United Kingdom

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Study design

Participant Group/Arm

EXPERIMENTAL: A: Tisotumab Vedotin + bevacizumab

Dose escalation: Tisotumab vedotin in combination with bevacizumab once every three weeks in previously treated patients

Intervention/Treatment

DRUG: Tisotumab Vedotin

Given into the vein (IV)

DRUG: Bevacizumab

Given via IV

Participant Group/Arm

EXPERIMENTAL: B: Tisotumab vedotin + pembrolizumab

Dose escalation: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients

Intervention/Treatment

DRUG: Tisotumab Vedotin

Given into the vein (IV)

DRUG: Pembrolizumab

Given via IV

Participant Group/Arm

EXPERIMENTAL: C: Tisotumab vedotin + carboplatin

Dose escalation: Tisotumab vedotin in combination with carboplatin once every three weeks in previously treated patients

Intervention/Treatment

DRUG: Tisotumab Vedotin

Given into the vein (IV)

DRUG: Carboplatin

Given via IV

Participant Group/Arm

EXPERIMENTAL: D: Tisotumab vedotin + carboplatin

Dose expansion:Tisotumab vedotin in combination with carboplatin once every three weeks in previously untreated patients

Intervention/Treatment

DRUG: Tisotumab Vedotin

Given into the vein (IV)

DRUG: Carboplatin

Given via IV

Participant Group/Arm

EXPERIMENTAL: E: Tisotumab vedotin + pembrolizumab

Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously untreated patients

Intervention/Treatment

DRUG: Tisotumab Vedotin

Given into the vein (IV)

DRUG: Pembrolizumab

Given via IV

Participant Group/Arm

EXPERIMENTAL: F: Tisotumab vedotin + pembrolizumab

Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients

Intervention/Treatment

DRUG: Tisotumab Vedotin

Given into the vein (IV)

DRUG: Pembrolizumab

Given via IV

Participant Group/Arm

EXPERIMENTAL: G: Tisotumab vedotin monotherapy

Dose expansion: Tisotumab vedotin monotherapy weekly for three weeks and 1 week off (28 day treatment cycle) in previously treated patients.

Intervention/Treatment

DRUG: Tisotumab Vedotin

Given into the vein (IV)

Participant Group/Arm

EXPERIMENTAL: H: Tisotumab vedotin + pembrolizumab + carboplatin +/- bevacizumab

Dose expansion: Tisotumab vedotin in combination with pembrolizumab and carboplatin with or without bevacizumab once every three weeks in previously untreated patients

Intervention/Treatment

DRUG: Tisotumab Vedotin

Given into the vein (IV)

DRUG: Bevacizumab

Given via IV

DRUG: Pembrolizumab

Given via IV

DRUG: Carboplatin

Given via IV

Study design table for Clinical Trial

Key eligibility criteria

Inclusion criteria
  • Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after standard of care treatments or are ineligible or intolerant to standard of care for recurrent or stage IVB cervical cancer (Arms A, B and C only).
  • Must have squamous, adenosquamous, or adenocarcinoma of the cervix and must not have received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H only).
  • Must have squamous, adenosquamous, or adenocarcinoma of the cervix and progressed on or after at least one but no more than two prior systemic therapies for recurrent or stage IVB cervical cancer (Arms F and G only).
  • Must have baseline measurable disease per RECIST v1.1.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (All Arms).
  • Is not pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial and for at least 6 months after the last trial treatment administration
  • Participants of childbearing potential must agree to use adequate contraception during and for 6 months after the last dose of trial treatment administration.
  • Must sign an informed consent form (ICF) indicating the trial subject understands the purpose of and procedures required for the trial and are willing to participate in the trial (All Arms).
Exclusion criteria
  • Has clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. (All Arms)
  • Has clinical signs or symptoms of gastrointestinal obstruction and requires parenteral hydration and/or nutrition. Post-operative obstructions within 4 weeks of abdominal surgery are permitted. (All Arms)
  • Has clinically significant bleeding issues or risks
    • Prior history (within 3 months) or current evidence of hemoptysis (1/2 teaspoon or more) (Arm A and bevacizumab-eligible participants in Arm H)
    • Recent (within 4 weeks of first dose of trial treatment) clinically significant gastrointestinal or vaginal bleeding requiring PRBC transfusion (Arms A and H only)
    • Recent (within 4 weeks of first dose of trial treatment) evidence of wound healing complications that require medical intervention (Arms A and H onl
  • Has active ocular surface disease at baseline. Subjects with prior history of cicatricial conjunctivitis are ineligible (All Arms).
  • Clinically significant cardiac disease
  • Requires anti-coagulation therapy (Arms A and H only)

Key dates

Study start date
  • February 2019
Estimated primary completion date
  • December 2024

Key endpoints

Primary Outcome Measures
Outcome Measure

Dose escalation: Dose Limiting Toxicities (DLTs)

Measure Description

To establish the MTD and RP2D of tisotumab vedotin in combination

Time Frame

DLTs will be identified during the first treatment cycle (21 day cycles)

Outcome Measure

Dose expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

Measure Description

Objective response is defined as confirmed partial response (PR) or complete response (CR)

Time Frame

approximately 2 years

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Number of adverse events (AEs)

Measure Description

Any untoward medical occurrence in a clinical trial participant whether or not considered related to the medicinal product.

Time Frame

up to 2 years

Outcome Measure

Dose escalation: ORR per RECIST v1.1

Measure Description

Objective response is defined as confirmed PR or CR.

Time Frame

approximately 2 years

Outcome Measure

Duration of Response (DOR) per RECIST v1.1 by investigator assessment

Measure Description

Will be calculated from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (PD) or death.

Time Frame

approximately 2 years

Outcome Measure

Time to Response (TTR) per RECIST v1.1 by investigator assessment

Measure Description

Will be calculated from the date of the first dose to the date of the initial documentation of response (CR or PR).

Time Frame

approximately 2 years

Outcome Measure

Progression free survival (PFS) per RECIST v1.1 by investigator assessment

Measure Description

The time from the date of the first trial drug administration to the date of the first documented disease progression or death due to any cause.

Time Frame

approximately 2 years

Outcome Measure

Overall Survival (OS)

Measure Description

The time from the date of the first trial drug administration to the date of death due to any cause.

Time Frame

approximately 2 years

Outcome Measure

Maximum concentration (Cmax) (All Arms except G)

Measure Description

Pharmacokinetic (PK) parameter

Time Frame

Up to 42 days

Outcome Measure

Cmax (Arm G only)

Measure Description

PK parameter

Time Frame

Up to 2 years

Outcome Measure

Trough Concentration (Ctrough) (All Arms)

Measure Description

PK parameter

Time Frame

Up to 2 years

Outcome Measure

Area under the concentration-time curve (AUC) (All Arms except G)

Measure Description

PK parameter

Time Frame

Through 21 days after first dose

Outcome Measure

AUC (Arm G only)

Measure Description

PK parameter

Time Frame

Through 8 days after first dose

Outcome Measure

Anti-drug antibodies (ADAs)

Measure Description

Time Frame

Up to 2 years

Secondary Outcome Measures table for Clinical Trial

Number of participants

214

Collaborators and investigators

Sponsor: Seagen Inc.

Collaborator: Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT), Belgian Gynaecological Oncology Group, GOG Foundation, Merck Sharp & Dohme LLC

This information is current as of February 12th 2024.
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More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT03786081