Ended Therapeutic confirmatory (Phase III) Second- or Third-Line Recurrent or Metastatic Cervical Cancer

A Randomized, Open-Label Trial to Compare Tisotumab Vedotin to Investigator's Choice Chemotherapy in Patients with Cervical Cancer

EU CTIS ID: 2023-503813-31-01

What this study is testing

To demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in subjects with second- or third-line (2L-3L) cervical cancer

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Age ≥18 years or considered an adult by local regulations, at time of consent.
10. Must agree not to breastfeed or donate ova, starting at the time of informed consent and continuing through 6 months after receiving the last dose of study drug administration.
11.Where required by local health authorities, has negative serology for hepatitis B surface antigen (HBsAg)/HBV DNA, or hepatitis C antibody (HCVAb) or RNA. Active hepatitis C is defined by a known positive HCVAb result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
12.Must provide a fresh or archival biopsy prior to the first planned administration of trial treatment, unless determined it is unfeasible after sponsor medical review.
13. Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
2. Must sign an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial prior to any other trial-related assessments or procedures.

You likely can't join if

1. Primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned in inclusion criterion 3
10.Prior anti-cancer therapy: a.Any prior treatment with MMAE-derived drugs. b.Radiotherapy within 21 days prior to the first administration of trial treatment. Subjects must have recovered from all clinically significant radiation-related toxicities. At least 42 days must have elapsed from the last administration of chemo radiotherapy. c. Is currently participating in or has participated in a trial of an investigational agent or device and received active treatment within 28days prior to the first dose of trial treatment.
11. Other: a. Ongoing significant, uncontrolled medical condition. b. Clinically significant active viral, bacterial, or fungal infection requiring IV or oral treatment with antimicrobial therapy ending <7 days prior to first study treatment administration. c. Clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. d. Participants with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration or nutrition at the time of the first dose of study treatment.
12. Has known seropositivity of human immunodeficiency virus (HIV); known medical history of hepatitis B or C infection. Note: No testing for HIV, hepatitis B, or hepatitis C is required, unless mandated by local health authorities. Exceptions include latent or controlled HIV infection for the global portion of the study.
13. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of tisotumab vedotin.
14. Is pregnant or intends to conceive children within 6 months of ending study treatment.

See the full eligibility criteria

Who can join

1. Age ≥18 years or considered an adult by local regulations, at time of consent.
10. Must agree not to breastfeed or donate ova, starting at the time of informed consent and continuing through 6 months after receiving the last dose of study drug administration.
11.Where required by local health authorities, has negative serology for hepatitis B surface antigen (HBsAg)/HBV DNA, or hepatitis C antibody (HCVAb) or RNA. Active hepatitis C is defined by a known positive HCVAb result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
12.Must provide a fresh or archival biopsy prior to the first planned administration of trial treatment, unless determined it is unfeasible after sponsor medical review.
13. Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
2. Must sign an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial prior to any other trial-related assessments or procedures.
3. Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and: a.Has experienced disease progression during or after treatment with standard of care systemic therapy 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 b.Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer. c.Is not a candidate for curative therapy, including but not limited to radiotherapy or exenterative surgery.
4. Measurable disease according to RECIST v1.1 as assessed by the investigator
5. Acceptable screening laboratory values including renal function, liver function and hematological status.
6. Has ECOG PS of 0 or 1 prior to randomization.
7. Has life expectancy of at least 3 months.
8. Has a negative serum pregnancy test for participants of childbearing potential. Participants that are postmenopausal or permanently sterilized can be considered as not having chilbearing potential.
9. Participants of childbearing potential must agree to use adequate contraception during and for 6 months after the last trial treatment administration.

What rules you out

1. Primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned in inclusion criterion 3
10.Prior anti-cancer therapy: a.Any prior treatment with MMAE-derived drugs. b.Radiotherapy within 21 days prior to the first administration of trial treatment. Subjects must have recovered from all clinically significant radiation-related toxicities. At least 42 days must have elapsed from the last administration of chemo radiotherapy. c. Is currently participating in or has participated in a trial of an investigational agent or device and received active treatment within 28days prior to the first dose of trial treatment.
11. Other: a. Ongoing significant, uncontrolled medical condition. b. Clinically significant active viral, bacterial, or fungal infection requiring IV or oral treatment with antimicrobial therapy ending <7 days prior to first study treatment administration. c. Clinically relevant bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. d. Participants with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration or nutrition at the time of the first dose of study treatment.
12. Has known seropositivity of human immunodeficiency virus (HIV); known medical history of hepatitis B or C infection. Note: No testing for HIV, hepatitis B, or hepatitis C is required, unless mandated by local health authorities. Exceptions include latent or controlled HIV infection for the global portion of the study.
13. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of tisotumab vedotin.
14. Is pregnant or intends to conceive children within 6 months of ending study treatment.
15. Is breast feeding and cannot discontinue breast feeding for the duration of the study and ≥6 months after the last study treatment administration.
16. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments.
17. Known allergies, hypersensitivity, or intolerance to study treatment or its excipients.
18. Has known psychiatric substance abuse disorders that would interfere with cooperating with the requirements of the study.
2. Clinically significant bleeding issues or risks
3. Clinically significant cardiac disease
4. History of intracerebral arteriovenous malformation, cerebral aneurysm, or stroke
5. Ocular surface disease Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or above, any prior episode of cicatricial conjunctivitis, or any prior episode of Stevens-Johnson syndrome.
6.Other cancer: known past or current malignancy other than inclusion diagnosis. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5year OS ≥90%) such as non-invasive basal cell or squamous cell skin carcinoma; non-invasive, superficial bladder cancer, and ductal carcinoma in situ.
7. Brain metastases are allowed if the following criteria are met: definitive therapy (eg, surgery or stereotactic brain radiotherapy) has been completed >8 weeks before the first dose of study treatment; no evidence of clinical or radiologic progression of the brain metastases; participant has completed perioperative corticosteroid therapy or steroid taper.
8.Surgery/procedures: major surgery within 4 weeks or minor surgery within 7 days prior to the first trial treatment administration. Subjects must have recovered adequately from the toxicity or complications from the intervention prior to starting trial treatment. Subjects who have planned major surgery during the treatment period must be excluded from the trial.
9.Peripheral neuropathy ≥grade 2.

The study team makes the final eligibility decision.

Where it's taking place

Israel
Argentina
China
Mexico
Singapore
Peru
Japan
Taiwan
Canada
United Kingdom
United States
Korea, Democratic People's Republic of
Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Israel; Argentina; China; Mexico; Singapore; Peru and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.