Phase 2
N=102
A Trial of Tisotumab Vedotin in Cervical Cancer
Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03438396 ↗Enrolled (actual)
102
Serious AEs
43.6%
Results posted
Nov 2021
Primary outcome: Primary: Percentage of Participants With Confirmed Objective Response (OR) as Assessed by the Independent Review Committee (IRC) — 23.8 Percentage of Participants — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- tisotumab vedotin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Seagen Inc.
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Confirmed Objective Response (OR) as Assessed by the Independent Review Committee (IRC) |
23.8 | 0.0002 sig |
| SECONDARY Duration of Response (DOR) as Assessed by the IRC |
8.3 | — |
| SECONDARY Percentage of Participants With Confirmed OR as Assessed by the Investigator |
20.8 | — |
| SECONDARY DOR as Assessed by the Investigator |
8.2 | — |
| SECONDARY Time to Response (TTR) as Assessed by the IRC |
1.4 | — |
| SECONDARY TTR as Assessed by the Investigator |
1.4 | — |
| SECONDARY Progression Free Survival (PFS) as Assessed by the IRC |
4.2 | — |
| SECONDARY PFS as Assessed by the Investigator |
4.1 | — |
| SECONDARY Overall Survival (OS) |
12.3 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
101; 44 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs |
34; 4; 3; 1; 1; 1 | — |
| SECONDARY Plasma Concentrations of Tisotumab Vedotin (HuMax-TF), Tisotumab Vedotin Antibody-drug Conjugate (HuMax-TF-ADC), and Free Monomethyl Auristatin E (MMAE) |
163.48; 41691.0; 150.0; 36941; 30.0; 38105 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) to Tisotumab Vedotin |
2; 5 | — |
Summary
A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.
Eligibility Criteria
Inclusion Criteria
- Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible.
- Measurable disease according to RECIST v1.1 as assessed by IRC.
- Age ≥ 18 years.
- Acceptable renal function
- Acceptable liver function
- Acceptable hematological status
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- A negative serum pregnancy test for patients of reproductive potential.
- All patients must provide a fresh or archival biopsy during screening.
- Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.
Exclusion Criteria
- Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer.
- Known past or current coagulation defects leading to an increased risk of bleeding;
- Ongoing major bleeding
- Active ocular surface disease
- Known past or current malignancy other than the inclusion diagnosis.
- Peripheral neuropathy grade ≥ 2
Data sourced from ClinicalTrials.gov (NCT03438396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.