A Phase 1/2 interventional study of Tisotumab Vedotin and Bevacizumab in Cervical Cancer, sponsored by Seagen, a wholly owned subsidiary of Pfizer. Terminated at 71 sites in 10 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Seagen, a wholly owned subsidiary of Pfizer · Phase 1/2, Interventional, and Treatment
This is an open label, multi-center trial of tisotumab vedotin monotherapy and in combination with bevacizumab, pembrolizumab, or carboplatin in subjects with recurrent or stage IVB cervical cancer.
The trial consists of two-parts a dose escalation part and an expansion part. The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) of the combinations have been determined in the dose escalation part.
The dose escalation part will occur in participants with cervical cancer who have progressed during or after standard of care therapy and who are intolerant or ineligible to receive standard of care treatments. Arm A will be conducted by escalating doses of both tisotumab vedotin and bevacizumab. Dose escalations of the tisotumab vedotin + pembrolizumab and tisotumab vedotin + carboplatin combinations (Arms B and C, respectively) will be conducted by combining fixed doses of either pembrolizumab or carboplatin with increasing doses of tisotumab vedotin.
The dose expansion part of this study (Arms D through H) will be conducted in 2 populations: participants with cervical cancer who have not received prior systemic therapy for recurrent or stage IVB cervical cancer (Arms D, E, and H) and participants with cervical cancer who have progressed on or after at least 1 but no more than 2 prior systemic therapies (Arms F and G).
Participants enrolled to Arms D, E, F and H will receive the RP2D of tisotumab vedotin established in the dose escalation part. Participants enrolled to Arm G will receive tisotumab vedotin weekly (at a dose lower than subjects in all other Arms) for three weeks and 1 week off (28-day treatment cycle).
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 214 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Seagen, a wholly owned subsidiary of Pfizer is the lead sponsor of 30 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 3 (27%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Has clinically significant bleeding issues or risks
Dose escalation: Tisotumab vedotin in combination with bevacizumab once every three weeks in previously treated patients
Drug: Tisotumab Vedotin · Drug: Bevacizumab
Dose escalation: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
Drug: Tisotumab Vedotin · Drug: Pembrolizumab
Dose escalation: Tisotumab vedotin in combination with carboplatin once every three weeks in previously treated patients
Drug: Tisotumab Vedotin · Drug: Carboplatin
Dose expansion:Tisotumab vedotin in combination with carboplatin once every three weeks in previously untreated patients
Drug: Tisotumab Vedotin · Drug: Carboplatin
Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously untreated patients
Drug: Tisotumab Vedotin · Drug: Pembrolizumab
Dose expansion: Tisotumab vedotin in combination with pembrolizumab once every three weeks in previously treated patients
Drug: Tisotumab Vedotin · Drug: Pembrolizumab
Dose expansion: Tisotumab vedotin monotherapy weekly for three weeks and 1 week off (28 day treatment cycle) in previously treated patients.
Drug: Tisotumab Vedotin
Dose expansion: Tisotumab vedotin in combination with pembrolizumab and carboplatin with or without bevacizumab once every three weeks in previously untreated patients
Drug: Tisotumab Vedotin · Drug: Bevacizumab · Drug: Pembrolizumab · Drug: Carboplatin
Given into the vein (IV)
Also known as: TIVDAK
Given via IV
Also known as: Avastin
Given via IV
Also known as: KEYTRUDA®
Given via IV
Also known as: Paraplatin
Dose escalation: Dose Limiting Toxicities (DLTs)
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)
Dose expansion: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Objective response is defined as confirmed partial response (PR) or complete response (CR)
Time frame: approximately 2 years
Number of adverse events (AEs)
Any untoward medical occurrence in a clinical trial participant whether or not considered related to the medicinal product.
Time frame: up to 2 years
Dose escalation: ORR per RECIST v1.1
Objective response is defined as confirmed PR or CR.
Time frame: approximately 2 years
Duration of Response (DOR) per RECIST v1.1 by investigator assessment
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
Time to Response (TTR) per RECIST v1.1 by investigator assessment
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
Progression free survival (PFS) per RECIST v1.1 by investigator assessment
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
Overall Survival (OS)
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
Maximum concentration (Cmax) (All Arms except G)
Pharmacokinetic (PK) parameter
Time frame: Up to 42 days
Cmax (Arm G only)
PK parameter
Time frame: Up to 2 years
Trough Concentration (Ctrough) (All Arms)
PK parameter
Time frame: Up to 2 years
Area under the concentration-time curve (AUC) (All Arms except G)
PK parameter
Time frame: Through 21 days after first dose
AUC (Arm G only)
PK parameter
Time frame: Through 8 days after first dose
Anti-drug antibodies (ADAs)
Time frame: Up to 2 years
This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Seagen, a wholly owned subsidiary of Pfizer