Melanoma Clinical Trial

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)

Summary

This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

Participant is at least 18 years of age.
Female participants of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the date of the first dose of study medication or be of non-childbearing potential.
Participant has an ECOG performance status of less than or equal to (<=)1.
Participant has adequate organ function.

Inclusion Criteria for Participants in Part 1 and Part 2 Cohorts A, B, and C:

Participant with advanced or metastatic solid tumor who meets the requirements for the part of the study/cohort he/she will participate in, as follows:
Part 2: Histologically proven advanced (unresectable) or metastatic solid tumor that is measurable by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 criteria
Inclusion Criteria for Participants in Part 2 Cohort D
Participants with advanced or metastatic NSCLC that is measurable by CT or MRI per RECIST version 1.1 criteria and meet the following criteria:
NSCLC histology includes squamous or non-squamous cell carcinoma.
Participants have received no more than 2 prior lines of therapy, which must include a platinum-based chemotherapy (for example [e.g.], cisplatin, carboplatin) and an anti-PD-(L)1 antibody.
Participants must have documented radiographic progression by RECIST version 1.1 criteria on prior anti-programmed cell death protein (PD)-1 or anti-PD-(L)1 therapy.
Biopsies -All participants enrolled must undergo a biopsy prior to study entry, and the biopsy tissue must be submitted to the central laboratory for all participants in order to determine TIM 3 expression level prior to first dose. If a participant has had a biopsy prior to entering the 35-day screening period and within approximately 12 weeks of study treatment, that biopsy may be accepted as the Baseline fresh biopsy.

Exclusion Criteria

History of Grade greater than or equal to (>=)3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
Participant has known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis.
Participant has a known additional malignancy that progressed or required active treatment within the last 2 years. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the Medical Monitor.
Participant is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection requiring systemic therapy.
Participant is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 150 days after the last dose of study treatment.
Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.

Exclusion Criteria for Participants in Part 2 Cohort D

A participant with negative (as determined by Central Testing Lab) or unevaluable TIM-3 expression from tissue obtained prior to study entry will not be eligible for the study.
Participant has received prior therapy as defined below:
Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent that resulted in permanent discontinuation due to an AE.
Prior treatment with an anti-lymphocyte activation gene (LAG)-3 or anti-TIM-3.
Radiologic or clinical progression <= 8 weeks after initiation of prior anti-PD-1 or anti-PD-L1 antibody.
Participants with known epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) translocation, or ROS1 mutation.
Participant has received a vaccine other than a vaccine against severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) infection ("Coronavirus Disease 2019" [COVID-19]) within 7 days of planned start of study therapy. The use of all COVID-19 vaccines is allowed, with the exception of COVID-19 vaccines using the recombinant adenoviral vector platform within 30 days of planned start of study therapy. If a COVID-19 vaccine using this platform is to be administered within 30 days of planned start of study therapy, this must first be discussed with and approved by the Sponsor's Medical Monitor.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

369

Study ID:

NCT02817633

Recruitment Status:

Recruiting

Sponsor:

Tesaro, Inc.

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There are 70 Locations for this study

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GSK Investigational Site
Goodyear Arizona, 85338, United States
GSK Investigational Site
Scottsdale Arizona, 85258, United States
GSK Investigational Site
Tucson Arizona, 85704, United States
GSK Investigational Site
Tucson Arizona, 85711, United States
GSK Investigational Site
Encinitas California, 92024, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Edward F McClay
Principal Investigator
GSK Investigational Site
Fountain Valley California, 92708, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Haresh S. Jhangiani
Principal Investigator
GSK Investigational Site
Los Angeles California, 90024, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Antoni Ribas
Principal Investigator
GSK Investigational Site
Los Angeles California, 90025, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Peter D Boasberg
Principal Investigator
GSK Investigational Site
San Marcos California, 92069, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Edward F McClay
Principal Investigator
GSK Investigational Site
Whittier California, 90606, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Merrill K Shum
Principal Investigator
GSK Investigational Site
Aurora Colorado, 80012, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Allen L. Cohn
Principal Investigator
GSK Investigational Site
Aurora Colorado, 80045, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Karl Lewis
Principal Investigator
GSK Investigational Site
Denver Colorado, 80218, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Allen L. Cohn
Principal Investigator
GSK Investigational Site
Denver Colorado, 80218, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Gerald Falchook
Principal Investigator
GSK Investigational Site
New Haven Connecticut, 06511, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Patricia M Lorusso
Principal Investigator
GSK Investigational Site
Washington District of Columbia, 20007, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Chul Kim
Principal Investigator
GSK Investigational Site
Jacksonville Florida, 32224, United States
GSK Investigational Site
Miami Beach Florida, 33140, United States
GSK Investigational Site
Sarasota Florida, 34232, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Judy S Wang
Principal Investigator
GSK Investigational Site
Tampa Florida, 33612, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Zeynep Eroglu
Principal Investigator
GSK Investigational Site
Atlanta Georgia, 30322, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Ragini Kudchadkar
Principal Investigator
GSK Investigational Site
Augusta Georgia, 30912, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Nagla Karim
Principal Investigator
GSK Investigational Site
Arlington Heights Illinois, 60005, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Richard S Siegel
Principal Investigator
GSK Investigational Site
Chicago Illinois, 60637, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Hedy Kindler
Principal Investigator
GSK Investigational Site
Niles Illinois, 60714, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Richard S Siegel
Principal Investigator
GSK Investigational Site
Iowa City Iowa, 52242, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Mohammed Milhem
Principal Investigator
GSK Investigational Site
Wichita Kansas, 67214, United States
GSK Investigational Site
Louisville Kentucky, 40202, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Jason Chesney
Principal Investigator
GSK Investigational Site
Pikeville Kentucky, 41501, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Christopher C. Croot
Principal Investigator
GSK Investigational Site
Rockville Maryland, 20850, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
John M Wallmark
Principal Investigator
GSK Investigational Site
Boston Massachusetts, 02114, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Justin Gainor
Principal Investigator
GSK Investigational Site
Detroit Michigan, 48202, United States
GSK Investigational Site
Rochester Minnesota, 55905, United States
GSK Investigational Site
Hackensack New Jersey, 07601, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Martin E Gutierrez
Principal Investigator
GSK Investigational Site
Bronx New York, 10461, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
GSKClinica[email protected]
Balazs Halmos
Principal Investigator
GSK Investigational Site
New York New York, 10016, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Janice Mehnert
Principal Investigator
GSK Investigational Site
Cincinnati Ohio, 45242, United States
GSK Investigational Site
Cleveland Ohio, 44106, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
David Bajor
Principal Investigator
GSK Investigational Site
Toledo Ohio, 43623, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Rex B Mowat
Principal Investigator
GSK Investigational Site
Eugene Oregon, 97401, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Joseph Fiorillo
Principal Investigator
GSK Investigational Site
Portland Oregon, 97213, United States
GSK Investigational Site
Bethlehem Pennsylvania, 18015, United States
GSK Investigational Site
Pittsburgh Pennsylvania, 15213, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Diwakar Davar
Principal Investigator
GSK Investigational Site
Charleston South Carolina, 29425, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Theodore G Gourdin
Principal Investigator
GSK Investigational Site
Greenville South Carolina, 29605, United States
GSK Investigational Site
Nashville Tennessee, 37203, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Erika Hamilton
Principal Investigator
GSK Investigational Site
Austin Texas, 78705, United States
GSK Investigational Site
Dallas Texas, 75246, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Carlos R Becerra
Principal Investigator
GSK Investigational Site
Fort Worth Texas, 76104, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Stephen Richey
Principal Investigator
GSK Investigational Site
Houston Texas, 77030, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Julio Peguero
Principal Investigator
GSK Investigational Site
Houston Texas, 77030, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Timothy Yap
Principal Investigator
GSK Investigational Site
Longview Texas, 75601, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Donald A. Richards
Principal Investigator
GSK Investigational Site
McAllen Texas, 78503, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Habib M. H. Ghaddar
Principal Investigator
GSK Investigational Site
San Antonio Texas, 78229, United States
GSK Investigational Site
Temple Texas, 76508, United States
GSK Investigational Site
Tyler Texas, 75702, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Donald A. Richards
Principal Investigator
GSK Investigational Site
Weslaco Texas, 78596, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Habib M. H. Ghaddar
Principal Investigator
GSK Investigational Site
Fairfax Virginia, 8613, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Alexander I. Spira
Principal Investigator
GSK Investigational Site
Kennewick Washington, 99336, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Ying Zhuo
Principal Investigator
GSK Investigational Site
Puyallup Washington, 98373, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Andrea Veatch
Principal Investigator
GSK Investigational Site
Tacoma Washington, 98405, United States More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Andrea Veatch
Principal Investigator
GSK Investigational Site
Madison Wisconsin, 53792, United States
GSK Investigational Site
Madrid Navarra, 28027, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Eduardo Castañón Álvarez
Principal Investigator
GSK Investigational Site
Barcelona , 08035, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Enriqueta Felip
Principal Investigator
GSK Investigational Site
Girona , 17007, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Joaquim Bosch Barrera
Principal Investigator
GSK Investigational Site
L'Hospitalet De Llobregat , 08908, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
María Jové Casulleras
Principal Investigator
GSK Investigational Site
Las Palmas De Gran Canaria , 35016, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Delvys Rodriguez Abreu
Principal Investigator
GSK Investigational Site
Madrid , 28040, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Victor Moreno García
Principal Investigator
GSK Investigational Site
Madrid , 28041, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Luis Paz Ares
Principal Investigator
GSK Investigational Site
Málaga , 29010, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Begoña Jiménez Rodríguez
Principal Investigator
GSK Investigational Site
Pamplona , 31008, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Eduardo Castañón Álvarez
Principal Investigator
GSK Investigational Site
Valencia , 46010, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Desamparados Roda
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

369

Study ID:

NCT02817633

Recruitment Status:

Recruiting

Sponsor:


Tesaro, Inc.

How clear is this clinincal trial information?

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