Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (innovaTV 301)
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|ClinicalTrials.gov Identifier: NCT04697628|
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : March 23, 2023
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This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent).
Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: tisotumab vedotin Drug: topotecan Drug: vinorelbine Drug: gemcitabine Drug: irinotecan Drug: pemetrexed||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||482 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer|
|Actual Study Start Date :||February 22, 2021|
|Estimated Primary Completion Date :||May 31, 2024|
|Estimated Study Completion Date :||February 28, 2028|
Experimental: Tisotumab vedotin
Tisotumab vedotin monotherapy
Drug: tisotumab vedotin
2.0 mg/kg every 3 weeks (Q3W)
Other Name: TIVDAK
Active Comparator: Chemotherapy
Investigator's choice of one chemotherapy treatment (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)
1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days
30 mg/m2 IV on Days 1 and 8, every 21 days
1000 mg/m2 IV on Days 1 and 8, every 21 days
100 or 125 mg/m2 IV weekly for 28 days, every 42 days
500 mg/m2 IV on Day 1, every 21 days
- Overall survival (OS) [ Time Frame: Up to approximately 2 years ]OS is defined as the time from the date of randomization to the date of death due to any cause.
- Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator [ Time Frame: Up to approximately 1 year ]PFS per investigator is defined as the time from the date of randomization to the first documentation of disease progression per RECIST v.1.1 by the investigator, or to date of death due to any cause, whichever occurs earlier.
- Confirmed objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator [ Time Frame: Up to approximately 6 months ]Confirmed objective response rate is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
- Time-to-response (TTR) as assessed by the investigator [ Time Frame: Up to approximately 6 months ]TTR is defined as the time from the date of randomization to the date of first confirmed objective response (CR or PR that is subsequently confirmed). Only participants with confirmed CR or PR will be included in the analysis.
- Duration of response (DOR) as assessed by the investigator [ Time Frame: Up to approximately 1 year ]DOR is defined as the time from the date of first confirmed objective response (CR or PR that is subsequently confirmed) to the date of first documented PD per RECIST v1.1 or death from any cause, whichever occurs first. Only participants with confirmed CR or PR will be included in the analysis.
- Incidence of adverse events (AEs) [ Time Frame: Up to approximately 2 years ]Analyses of AEs will be summarized descriptively
- Health-related quality of life as assessed by EQ-5D-5L index [ Time Frame: Up to approximately 2 years ]EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of HRQOL that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
- Health-related quality of life as assessed by EQ-5D visual analog scale (VAS) [ Time Frame: Up to approximately 2 years ]EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of HRQOL that can be used in a wide range of health conditions and treatments. The EQ-5D-5L consists of a descriptive system and the EQ VAS. The EQ VAS records the participant's self-rated health on a vertical VAS. This can be used as a quantitative measure of health outcome that reflects the participant's own judgment.
- Health-related quality of life as assessed by EORTC-QLQ-C30 [ Time Frame: Up to approximately 6 months ]The QLQ-C30 is a validated questionnaire developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess the quality of life of participants with cancer in multicultural clinical research settings.
- Health-related quality of life as assessed by EORTC-QLQ-CX24 [ Time Frame: Up to approximately 6 months ]The EORTC-QLQ-CX24 is a validated questionnaire developed by the EORTC to assess the quality of life in patients who are treated for cervical cancer both in clinical studies and in clinical practice.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and:
Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either:
- paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or
- paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or
- paclitaxel + topotecan/nogitecan + bevacizumab + anti-PD-(L)1 agent
- Note: In cases where bevacizumab and/or anti-PD-(L)1 agent is not a standard of care therapy or the participant was ineligible for such treatment according to local standards, prior treatment with bevacizumab and/or anti-PD-(L)1 agent is not required.
- Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a systemic therapy regimen. Single agent therapy with an anti-PD(L)1 agent for r/mCC cancer should be counted.
- Measurable disease according to RECIST v1.1 as assessed by the investigator.
- Has ECOG performance status of 0 or 1 prior to randomization.
- Has life expectancy of at least 3 months.
- Has primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned as part of the inclusion criteria above.
- Has clinically significant bleeding issues or risks. This includes known past or current coagulation defects leading to an increased risk of bleeding; diffuse alveolar hemorrhage from vasculitis; known bleeding diathesis; ongoing major bleeding; trauma with increased risk of life-threatening bleeding or history of severe head trauma or intracranial surgery within 8 weeks of trial entry.
- Has any history of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke (transient ischemic attack >1 month prior to screening is allowed).
- Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis (e.g. Wagner syndrome, atopic keratoconjunctivitis, autoimmune disease affecting the eyes), ocular Stevens-Johnson syndrome or toxic epidermal necrolysis, mucus pemphigoid, and participants with penetrating ocular transplants. Cataracts alone is not an exclusion criterion.
- Major surgery within 4 weeks or minor surgery within 7 days prior to the first study treatment administration.
- Peripheral neuropathy ≥grade 2.
- Any prior treatment with monomethyl auristatin E (MMAE)-containing drugs.
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697628
|Contact: Seagen Trial Information Supportfirstname.lastname@example.org|
|Study Director:||Leo Nicacio, MD||Seagen Inc.|
|Study Director:||Liz Whalley, PhD||Seagen Inc.|
|Responsible Party:||Seagen Inc.|
|Other Study ID Numbers:||
ENGOT cx-12 ( Other Identifier: European Network of Gynaecological Oncological Trial )
GOG-3057 ( Other Identifier: GOG Foundation )
|First Posted:||January 6, 2021 Key Record Dates|
|Last Update Posted:||March 23, 2023|
|Last Verified:||March 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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