Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called tisotumab vedotin on patients with locally advanced or metastatic solid tumors. These are types of cancers that have spread from their original location to other parts of the body. The study aims to evaluate how well tisotumab vedotin works on its own and in combination with other treatments. In some parts of the study, tisotumab vedotin is combined with pembrolizumab, a medication that helps the immune system fight cancer, and a platinum agent, which is a type of chemotherapy drug.

The study is divided into several parts. In some parts, patients will receive tisotumab vedotin alone, while in others, it will be given alongside pembrolizumab or both pembrolizumab and a platinum agent like cisplatin or carboplatin. These medications are administered through an intravenous infusion, which means they are given directly into the bloodstream through a vein. The study will observe the effects of these treatments over time to understand their impact on the cancer and any side effects that may occur.

The purpose of this study is to assess the antitumor activity of tisotumab vedotin and its combinations in treating these advanced cancers. The study will monitor how the tumors respond to the treatment, how long it takes for a response to occur, and the overall survival of the patients. This information will help determine the effectiveness and safety of the treatment options being tested.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility is based on having relapsed, locally advanced, or metastatic colorectal or pancreatic cancer, squamous non-small cell lung cancer (sqNSCLC), or squamous cell carcinoma of the head and neck (SCCHN) that has not responded to previous treatments.

2 treatment assignment

Participants are assigned to different parts of the study based on their specific medical condition and previous treatments.

The study is divided into several parts, each evaluating the effectiveness of tisotumab vedotin alone or in combination with other medications such as pembrolizumab and platinum-based drugs like cisplatin or carboplatin.

3 medication administration

Medications are administered through intravenous infusion. The specific drugs and combinations depend on the part of the study the participant is enrolled in.

For example, tisotumab vedotin may be given alone or with pembrolizumab and a platinum agent. The frequency and duration of administration are determined by the study protocol.

4 monitoring and follow-up

Participants undergo regular monitoring to assess the response to treatment. This includes imaging tests and other evaluations to measure tumor size and progression.

The study aims to evaluate the antitumor activity of the treatments, as well as the safety and any side effects experienced by participants.

5 completion and final assessment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the study medications.

Participants may continue to be monitored for long-term outcomes and overall survival as part of the study’s objectives.

Who Can Join the Study?

Patients must have relapsed (cancer has returned), locally-advanced (cancer has spread nearby), or metastatic (cancer has spread to other parts of the body) colorectal or pancreatic cancer, squamous non-small cell lung cancer (sqNSCLC), or squamous cell carcinoma of the head and neck (SCCHN) that has not responded to previous treatments and cannot be treated with standard therapy.
Patients with SCCHN must have experienced disease progression (cancer has worsened) after their most recent treatment. They should have had no more than 1 or 2 previous treatments for cancer that has come back or spread.
Patients must have a measurable disease according to specific guidelines, meaning the cancer can be measured in size by the doctor.
Patients with SCCHN must have a CPS (Combined Positive Score) of 1 or more to be eligible for certain parts of the study. CPS is a way to measure a protein called PD-L1 in cancer cells.
Patients must be able to provide a tissue sample for testing. This sample can be a recent biopsy or an older one taken within the last 2 years.
Both men and women can participate in the study.
Participants must be within certain age ranges, typically adults.

Who Cannot Join the Study?

Patients who have a different type of cancer that is not a solid tumor. A solid tumor is a mass of tissue that does not include liquid areas or cysts.
Patients who have not been diagnosed with locally advanced or metastatic disease. Locally advanced means the cancer has spread to nearby tissues or lymph nodes, and metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or do not agree to participate.
Patients who are part of a vulnerable population that the study is not designed to include.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Hospital Universitario De Navarra	Pamplona	Spain
University Hospital Jena KöR	Jena	Germany
Hospital Clinico San Carlos	Madrid	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Foch	Suresnes	France
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Vincentius-Diakonissen-Kliniken gAG	Karlsruhe	Germany
Hospital Son Llatzer	Palma	Spain
Azienda USL Toscana Centro	Prato	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
L’Hopital Prive Du Confluent	Nantes	France
Cjufme Legz Btatko	Lyon	France
Ilkmjcvv Rfoethdbm Pqm Lv Syozqe Dqh Tfpgan Duqz Aqhpwqy Iisn Sulctt	Meldola	Italy
Aapzvoyylf Ptfsedko Huwzrfxd Da Mernlcagb	Marseille	France
Bbdqcjgq Uxfbgdwnhr Hqxhxoyw Cgctrm	Besançon	France
Uudgrkqpvppygqlwfdjzu Wdlgsinob Axp	Wuerzburg	Germany
Mnqxjanjyrxruapjneqkplzewo Hgpvlwvpwhwdzfud	Halle (Saale)	Germany
Iihelhik Ccmqew Dfwihrjiovudhxxnf	L'hospitalet De Llobregat	Spain
Udohcbeuqb Msrkt Gbssplf Oa Chjqpdoqi	Catanzaro	Italy
Hxsgbbln Vstv dkilesgg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.05.2018
Germany	Not recruiting	31.05.2018
Italy	Not recruiting	31.05.2018
Spain	Not recruiting	31.05.2018

Trial locations

Investigated drugs:

Tisotumab Vedotin is a medication being studied for its ability to fight cancer. It is used in this trial to see how well it works on its own in treating advanced or metastatic solid tumors. This means it is being tested to see if it can help shrink or control tumors that have spread or are difficult to treat.

Pembrolizumab is another medication involved in this trial. It is used in combination with Tisotumab Vedotin to see if the two drugs together can improve the treatment of advanced or metastatic solid tumors. Pembrolizumab is known to help the immune system attack cancer cells.

Platinum Agent refers to a type of chemotherapy drug that contains platinum. In this trial, it is used along with Tisotumab Vedotin and Pembrolizumab to evaluate if this combination can enhance the treatment’s effectiveness against advanced or metastatic solid tumors. Platinum agents are commonly used in cancer treatment to damage the DNA of cancer cells, which can help stop their growth.

Investigated diseases:

Locally Advanced or Metastatic Disease in Solid Tumors – This condition refers to cancer that has spread beyond its original site to nearby tissues or distant parts of the body. In locally advanced disease, the tumor has grown into nearby structures or lymph nodes but has not spread to distant organs. Metastatic disease indicates that cancer cells have traveled through the bloodstream or lymphatic system to form new tumors in other organs. The progression of this disease can vary depending on the type of cancer and its location. Symptoms may include pain, fatigue, and weight loss, among others, depending on the organs affected. The disease’s behavior and impact on the body can differ significantly based on the specific type of solid tumor involved.

Trial ID:

2023-503812-34-00

Protocol code:

SGNTV-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?