Tisotumab Vedotin for Cancer
(innovaTV 207 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called tisotumab vedotin to determine its effectiveness in treating certain solid tumors and to identify any side effects. The study consists of several parts and includes combinations with other drugs such as pembrolizumab (an immunotherapy drug), carboplatin, and cisplatin. Suitable candidates include those with head and neck squamous cell carcinoma (HNSCC) or squamous non-small cell lung cancer (sqNSCLC) whose disease has progressed after specific previous treatments. Participants should have measurable tumors and no other severe health conditions that might interfere with the trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it is common for clinical trials to have restrictions on certain medications, especially those that might interfere with the study drug. It's best to discuss your current medications with the trial coordinators.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatment called tisotumab vedotin has been tested for safety in people. In earlier studies, this treatment demonstrated a safety profile that patients could manage. For example, one study found that administering a dose of 2 mg/kg every three weeks was both effective and tolerable for patients with certain types of cancer. This indicates that the treatment is generally well-tolerated, although safety can vary based on individual health conditions.
When combined with other drugs like pembrolizumab, carboplatin, or cisplatin, tisotumab vedotin also maintained a manageable safety profile. This suggests that the side effects were not too severe or difficult to manage.
It's important to note that while the treatment has shown promising safety results, side effects can still occur. Some studies have mentioned eye-related side effects as a possible concern. Prospective trial participants should consult their doctor to understand what this means for their health.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Tisotumab Vedotin because it offers a novel approach to treating certain cancers, such as head and neck squamous cell carcinoma (HNSCC) and squamous non-small cell lung cancer (sqNSCLC). Unlike traditional chemotherapy, which attacks all rapidly dividing cells, Tisotumab Vedotin specifically targets cancer cells by binding to tissue factor, a protein often overexpressed in these tumors. This targeted method aims to reduce damage to healthy cells and potentially minimize side effects. Additionally, combinations with pembrolizumab and platinum-based drugs like carboplatin or cisplatin may enhance its effectiveness by leveraging multiple mechanisms to fight cancer. This innovative targeting approach and combination strategy make Tisotumab Vedotin a promising new option in the fight against these challenging cancers.
What evidence suggests that this trial's treatments could be effective for solid tumors?
Research has shown that tisotumab vedotin yields promising results in treating some solid tumors. In earlier studies, about 18% of patients experienced tumor shrinkage or disappearance, meaning nearly one in five patients saw positive changes. In this trial, participants may receive tisotumab vedotin alone or with other treatments. Specifically, when combined with pembrolizumab, another cancer drug, tisotumab vedotin was particularly effective against head and neck cancers. Adding carboplatin, another treatment option in this trial, enhanced its effectiveness, especially for cervical cancer. These findings suggest that tisotumab vedotin, whether used alone or with other treatments, could be a viable option for certain cancers.16789
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for patients with certain solid tumors like colorectal, pancreatic, and non-small cell lung cancer who have seen their disease progress after treatment. They must have tried specific therapies depending on the type of cancer and can't be candidates for standard therapy. Participants need a performance status score of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tisotumab vedotin alone or in combination with other anticancer drugs in various schedules across seven parts of the study
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Pembrolizumab
- Tisotumab Vedotin
Tisotumab Vedotin is already approved in United States for the following indications:
- Recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seagen Inc.
Lead Sponsor
Dr. Roger Dansey
Seagen Inc.
Chief Medical Officer since 2018
MD from University of Witwatersrand
David R. Epstein
Seagen Inc.
Chief Executive Officer since 2022
BSc in Pharmacy from Rutgers University, MBA from Columbia University
Seagen, a wholly owned subsidiary of Pfizer
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Genmab
Industry Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen