Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Recurrence

Uterine Cervical Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Dostarlimab

Immunoglobulins

10 Participants will complete study procedures as follows:

* Baseline visit.
* Imaging tests at baseline visit, at week 9, and then every 12 weeks.
* Cycle 1 through End of Treatment (up to 2 years of treatment):

  • Day 1 of 21 Day cycle: Dostarlimab 1x daily and Cobolimab 1x daily.
* End of Treatment visit with blood tests and imaging tests.
* Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests.

If \>= 2 participants with objective responses, then 19 additional participants will be enrolled.

14 Participants will complete study procedures as follows:

* Baseline visit.
* Imaging tests at baseline visit, at week 9, and then every 12 weeks.
* Cycle 1 through End of Treatment (up to 2 years of treatment):

  • Day of 21 Day cycle: Predetermined dose of Dostarlimab 1x daily. Predetermined dose of Cobolimab 1x daily.
* End of Treatment visit with blood tests and imaging tests.
* Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests.

If \>= 2 participants with objective responses, then 23 additional participants will be enrolled.

Humanized monoclonal antibody, 50mg/mL type 1 borosilicate clear glass vial, via intravenous infusion per protocol.

Humanized anti-TIM-3 monoclonal antibody, 20mg/mL single-use vial, via intravenous infusion per protocol.

Cobolimab

Meghan Shea, MD

Susana Campos, MD

Oladapo Yeku, MD

This research is being done to determine how effective dostarlimab in combination with cobolimab is in metastatic or recurrent cervical cancer.

This is a non-randomized, open-label, two-arm phase 2 trial of dostarlimab and cobolimab for participants with metastatic or recurrent cervical cancer who have or have not been treated with immunotherapy previously.

The names of the study drugs involved in this study are:

* Cobolimab (a type of monoclonal antibody)
* Dostarllimab (a type of monoclonal antibody)

The U.S. Food and Drug Administration (FDA) has not approved cobolimab as a treatment for cervical cancer.

The FDA has not approved dostarlimab for cervical cancer but it has been approved for other uses.

The study procedures including, screening for eligibility, treatment visits, blood tests, x-rays, Computerized Tomograph (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission Tomograph (PET) scans.

Participants will be followed for up to 7 years.

It is expected that about 66 people will take part in this research study.

GlaxoSmithKline is funding this research study by providing funding and the study drugs.

Dostarlimab and Cobolimab in Advanced Cervical Cancer

A Phase 2 Study of Dostarlimab in Combination With Cobolimab in Advanced Cervical Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

ORR based on irRECIST is defined as the proportion of participants who achieved partial response or complete response during study treatment based on immune-related RECIST criteria.

PFS is defined as the time from registration to the earlier of progression (PD) or death due to any cause based on Kaplan-Meier methodology. Participants alive without disease progression are censored at date of last disease evaluation.

OS is defined as the time from registration to death due to any cause, or censored at date last known alive based on Kaplan-Meier methodology.

PFS is defined as the time from registration to disease progression or censored at date of last contact.

Grade 3-5 AE rate is defined as the proportion of participants who experienced grade 3-5 adverse event based on the Common Toxicity Criteria for Adverse Events version 5.0 as reported on case report form.

GlaxoSmithKline

Meghan Shea

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Death

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Docetaxel

Tubulin Modulators

Antimitotic Agents

GSK Clinical Trials

This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced Non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

Participants will receive treatment in a 2:2:1 randomisation; cobolimab + dostarlimab + docetaxel; dostarlimab + docetaxel; docetaxel.

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy

A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Nonsmall Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)

IPD for this study will be made available via the Clinical Study Data Request site.

OS is defined as survival from the date of randomization to the date of death by any cause

Confirmed ORR is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment

PFS is defined as the length of time until disease progression, from the time of randomization to the earliest date of assessment of disease progression based on RECIST version 1.1 by Investigator assessment or death by any cause

DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on RECIST version 1.1 by Investigator assessment or death, whichever occurs first

TTD in lung cancer is defined as time from randomization to meaningful deterioration on a composite endpoint of dyspnea, chest pain, and cough, from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13 item Lung Cancer Module (EORTC QLQ LC13)

EORTC QLQ-C30 is a questionnaire used to measure health related quality of life (HRQoL) in participants with cancer.

EORTC QLQ LC13 is a lung cancer specific questionnaire module designed to supplement the EORTC QLQ C30.

Blood and urine samples will be collected for the assessment of hematology, clinical chemistry, thyroid function and urinalysis lab parameters

Performance status will be assessed using the ECOG performance status scale. Scales range from grade 0 to 4, grade 0 denoting fully active and grade 4 completely disabled.

Participants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses.

Participants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab.

Participants will be administered an IV infusion of dostarlimab monotherapy (1 cohort will receive dostarlimab every 3 weeks and 1 cohort will receive dostarlimab every 6 weeks).

Participants will be administered IV infusions of dostarlimab followed by belrestotug, every 3 weeks.

Participants will be administered an IV infusion of dostarlimab followed by belrestotug followed by GSK6097608 every 3 weeks.

Participants will be administered an IV infusion of cobolimab followed by dostarlimab

GSK6097608 will be administered as an IV infusion.

GSK6097608

Dostarlimab will be administered as an IV infusion.

Cobolimab will be administered as an IV infusion.

Belrestotug will be administered as an IV infusion.

Belrestotug

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Centre

Omid Hamid

Frank Stephen Hodi

Reva Elaine Schneider

Jordi Rodón Ahnert

Drew W Rasco

Scott A Laurie

Lillian Siu

Yoshitaka Zenke

Noboru Yamamoto

Dong-Wan Kim

Myung-Ju Ahn

This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy (Arm D); and in combination with belrestotug (Arm E); and with GSK6097608 + belrestotug (Arm F) in Japanese and Chinese participants. The study may assess the PK/PD cohorts for Arm E and/or Arm F in participants outside of China and Japan. Additionally, dostarlimab will be given in combination with cobolimab in Japanese participants. Drug name mentioned as belrestotug, GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as belrestotug.

Participants will receive treatment in different dose escalation arms of the study.

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors

A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dostarlimab and Cobolimab in Advanced Cervical Cancer	NCT06238635	Cervical Cancer Advanced Cervic... Metastatic Cerv... Metastatic Cerv... Recurrent Cervi...	Dostarlimab Cobolimab	18 Years -	Beth Israel Deaconess Medical Center
Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy	NCT04655976	Lung Cancer, No...	Cobolimab Dostarlimab Docetaxel	18 Years -	GlaxoSmithKline
Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors	NCT04446351	Neoplasms	GSK6097608 Dostarlimab Cobolimab Belrestotug	18 Years -	GlaxoSmithKline
Dostarlimab and Cobolimab in Advanced Cervical Cancer	NCT06238635	Cervical Cancer Advanced Cervic... Metastatic Cerv... Metastatic Cerv... Recurrent Cervi...	Dostarlimab Cobolimab	18 Years -	Beth Israel Deaconess Medical Center

Spots Global Cancer Trial Database for cobolimab

Every month we try and update this database with for cobolimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cobolimab

Every month we try and update this database with for cobolimab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cobolimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.