Tisotumab Vedotin for Cancer

(innovaTV 207 Trial)

Not currently recruiting at 238 trial locations
ST
Overseen BySeagen Trial Information Support
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

Why 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?

PC

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

I have colorectal cancer and have been treated with specific drugs but no more than 3 times for advanced disease.
I have taken a tyrosine kinase inhibitor and had no more than 4 treatments for my metastatic condition.
I have pancreatic cancer and have had only one treatment for it when it could not be surgically removed.
See 13 more

Exclusion Criteria

I have lung disease but don't need steroids or long-term oxygen.
I have or had another type of cancer besides the one I am seeking treatment for.
I have pain from my cancer that isn't relieved by treatment.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tisotumab vedotin alone or in combination with other anticancer drugs in various schedules across seven parts of the study

Up to 3 years
Visits every 3 to 6 weeks depending on the part

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Cisplatin
  • Pembrolizumab
  • Tisotumab Vedotin
Trial Overview The study tests tisotumab vedotin alone or combined with pembrolizumab and/or platinum-based chemotherapy (carboplatin or cisplatin) across seven parts with varying schedules. It aims to determine effectiveness against solid tumors and identify potential side effects from these treatments.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Group I: Part G: Tisotumab Vedotin Combination Therapy - Q2W ScheduleExperimental Treatment3 Interventions
Group II: Part F: Tisotumab Vedotin Combination Therapy - Q2W ScheduleExperimental Treatment2 Interventions
Group III: Part E: Tisotumab Vedotin - 2Q4W ScheduleExperimental Treatment1 Intervention
Group IV: Part D: Tisotumab Vedotin Combination Therapy - Q3W ScheduleExperimental Treatment4 Interventions
Group V: Part C: Tisotumab Vedotin - 2Q4W ScheduleExperimental Treatment1 Intervention
Group VI: Part B: Tisotumab Vedotin - 3Q4W ScheduleExperimental Treatment1 Intervention
Group VII: Part A: Tisotumab Vedotin - Q3W ScheduleExperimental Treatment1 Intervention

Tisotumab Vedotin is already approved in United States for the following indications:

🇺🇸
Approved in United States as Tivdak for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seagen Inc.

Lead Sponsor

Trials
212
Recruited
73,800+
Founded
1997
Headquarters
Bothell, USA
Known For
Antibody-Drug Conjugates
Top Products
Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)
Dr. Roger Dansey profile image

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein profile image

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

Trials
20
Recruited
4,900+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Trials
76
Recruited
15,300+

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

Published Research Related to This Trial

In a study of 463 patients with metastatic colorectal cancer, those treated with panitumumab who experienced more severe skin toxicity had significantly longer overall survival and progression-free survival compared to those with less severe toxicity.
The severity of skin toxicity, as measured by patient-reported outcomes, was inversely related to health-related quality of life scores, indicating that while skin toxicity can be bothersome, it may correlate with better treatment outcomes, especially in patients with wild-type KRAS tumors.
Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy.Peeters, M., Siena, S., Van Cutsem, E., et al.[2018]
A total of 3120 adverse event cases related to avapritinib were reported to the FDA, with 44% occurring within the first 30 days of treatment, highlighting the importance of monitoring patients closely during this period.
The study found that elderly male patients are at a higher risk for serious adverse events, indicating that clinicians should exercise caution when prescribing avapritinib to this demographic.
A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database.Rong, L., Xie, M., Jiang, M., et al.[2023]
Tisotumab vedotin (Tivdak™) is an antibody-drug conjugate specifically designed to target tissue factor in tumors, combining a monoclonal antibody with a potent drug, monomethyl auristatin E (MMAE).
It received accelerated approval in the USA for treating recurrent or metastatic cervical cancer in adults who have experienced disease progression after chemotherapy, based on promising results from a phase II trial.
Tisotumab Vedotin: First Approval.Markham, A.[2022]

Citations

NCT02001623 | Tisotumab Vedotin (HuMax®-TF-ADC) ...The purpose of the trial is to establish the tolerability of HuMax-TF-ADC in a mixed population of patients with specified solid tumors. Detailed Description.
Tisotumab vedotin in head and neck squamous cell ...TV demonstrated encouraging antitumor activity in a heavily pretreated r/m HNSCC population with a manageable safety profile consistent with previous TV ...
Therapeutic Potential of Tisotumab Vedotin in the Treatment of ...First Trials in Solid Tumours and Cervical Cancer. In phase I/II studies in patients with metastatic solid tumors expressing TF, TV ...
Efficacy and Safety Study of Tisotumab Vedotin for Patients ...This trial will study tisotumab vedotin to find out whether it is an effective treatment alone or with other anticancer drugs for certain solid tumors and ...
Tisotumab vedotin (TV) + pembrolizumab (pembro) in first- ...TV + pembro demonstrated encouraging, durable antitumor activity with a manageable and acceptable safety profile as a 1L regimen for patients with r/mCC.
A phase I/II safety study of tisotumab vedotin (HuMaxTisotumab vedotin demonstrated a manageable toxicity profile. Recommended Ph II dose was identified as 2.0 mg/kg q3Wk.
7.tivdakhcp.comtivdakhcp.com/safety/
Safety | Tivdak® (tisotumab vedotin-tftv) HCP SiteReview information on Tivdak® (tisotumab vedotin-tftv) safety data, including adverse reactions and BOXED WARNING for OCULAR TOXICITY.
8.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37496366/
Exposure-safety and exposure-efficacy analyses for ...These results align with clinical findings showing TV 2 mg/kg (≤200 mg for patients ≥100 kg) every 3 weeks is efficacious and tolerable for patients with r/mCC.
Efficacy and Safety Study of Tisotumab Vedotin for Patients ...The primary goal of this trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumors. Patients ...
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