Clinical Trial - NCT02817633

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

Recruiting

Sponsor: Tesaro, Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02817633

Protocol Info

Short Description: Phase 1 of TSR-022 in Advanced Solid Tumors
Long Description: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors
MGH Status: Open
Sponsor: Tesaro
Disease Program: Phase I

Next Steps


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Purpose

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.
Condition Title Intervention Phase
Neoplasms TSR-022 Nivolumab TSR-042 TSR-033 Docetaxel Pemetrexed Cisplatin Carboplatin Phase 1
Study Type Interventional
Official Title A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)

Primary Outcome Measures

Part 1: Number of participants achieving dose limiting toxicity (DLTs) [Time Frame: Up to 2 years] [Designated as safety issue: ]

Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TAEs), TEAEs leading to death and immune-related adverse events (irAEs) [Time Frame: Up to 2 years] [Designated as safety issue: ]

Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications [Time Frame: Up to 2 years] [Designated as safety issue: ]

Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 [Time Frame: Up to 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

Number of participants with anti-TSR-022, anti-TSR-042 and anti-TSR-033 antibodies [Time Frame: Up to 2 years] [Designated as safety issue: ]

Part 1: ORR by RECIST v 1.1 and immune-related RECIST (irRECIST) [Time Frame: Up to 2 years] [Designated as safety issue: ]

Parts 1 and 2: Duration of response (DOR) by RECIST v 1.1 and irRECIST [Time Frame: Up to 2 years] [Designated as safety issue: ]

Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1 and irRECIST [Time Frame: Up to 2 years] [Designated as safety issue: ]

Parts 1 and 2: Progression-free survival (PFS) by RECIST v 1.1 and irRECIST [Time Frame: Up to 2 years] [Designated as safety issue: ]

Parts 1 and 2: Overall survival (OS) [Time Frame: Up to 2 years] [Designated as safety issue: ]

Part 1a: Maximum plasma concentration (Cmax) of TSR-022 when administered as monotherapy [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose.] [Designated as safety issue: ]

Part 1b: Cmax of TSR-022 in combination with nivolumab [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1c: Cmax of TSR-022 when administered in combination with TSR-042 [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1d: Cmax of TSR-022 when administered in combination with TSR-042 and TSR-033 [Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose] [Designated as safety issue: ]

Part 1e: Cmax of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1f: Cmax of TSR-022 in combination with TSR-042 and docetaxel [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1g: Cmax of TSR-022 in combination with TSR-042, pemetrexed and cisplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1h: Cmax of TSR-022 in combination with TSR-042, pemetrexed, and carboplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 2: Cmax of TSR-022 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1b: Cmin of TSR-022 in combination with nivolumab [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1c: Cmin of TSR-022 in combination with TSR-042 [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose.] [Designated as safety issue: ]

Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033 [Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose] [Designated as safety issue: ]

Part 1e: Cmin of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1f: Cmin of TSR-022 in combination with TSR-042 and docetaxel [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1g: Cmin of TSR-022 in combination with TSR-042, pemetrexed and cisplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1h: Cmin of TSR-022 in combination with TSR-042, pemetrexed and carboplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 2: Cmin of TSR-022 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042 [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033 [Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose] [Designated as safety issue: ]

Part 1e: AUC (0-inf) of in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1f: AUC (0-inf) of TSR-022 in combination with TSR-042 and docetaxel [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1g: AUC (0-inf) of TSR-022 in combination with TSR-042, pemetrexed and cisplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1h: AUC (0-inf) of TSR-022 in combination with TSR-042, pemetrexed and carboplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 2: AUC (0-inf) of TSR-022 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1a: Area under the concentration × time curve at steady state (AUCss) of TSR-022 as monotherapy [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1b: AUCss of TSR-022 in combination with nivolumab [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1c: AUCss of TSR-022 in combination with TSR-042 [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1d: AUCss of TSR-022 in combination with TSR-042 and TSR-033 [Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose] [Designated as safety issue: ]

Part 1e: AUCss of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1f: AUCss of TSR-022 in combination with TSR-042 and docetaxel [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1g: AUCss of TSR-022 in combination with TSR-042, pemetrexed and cisplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1h: AUCss of TSR-022 in combination with TSR-042, pemetrexed and carboplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 2: AUCss of TSR-022 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1a: Maximum plasma concentration at steady state (Cmax,ss) of TSR-022 as monotherapy [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1b: Cmax,ss of TSR-022 in combination with nivolumab [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1c: Cmax,ss of TSR-022 in combination with TSR-042 [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1d: Cmax,ss of TSR-022 in combination with TSR-042 and TSR-033 [Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose] [Designated as safety issue: ]

Part 1e: Cmax,ss of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1f: Cmax,ss of TSR-022 in combination with TSR-042 and docetaxel [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1g: Cmax,ss of TSR-022 in combination with TSR-042, pemetrexed and cisplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1h: Cmax,ss of TSR-022 in combination with TSR-042, pemetrexed and carboplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 2: Cmax,ss of TSR-022 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1a: Minimum plasma concentration at steady state (Cmin,ss) of TSR-022 022 as monotherapy [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1b: Cmin,ss of TSR-022 in combination with nivolumab [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1c: Cmin,ss of TSR-022 in combination with TSR-042 [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1d: Cmin,ss of of TSR-022 in combination with TSR-042 and TSR-033 [Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose] [Designated as safety issue: ]

Part 1e: Cmin,ss of of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1f: Cmin,ss of of TSR-022 in combination with TSR-042 and docetaxel [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1g: Cmin,ss of TSR-022 in combination with TSR-042, pemetrexed and cisplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1h: Cmin,ss of TSR-022 in combination with TSR-042, pemetrexed and carboplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 2: Cmin,ss of TSR-022 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042 [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033 [Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose] [Designated as safety issue: ]

Part 1e: AUC (0-last) of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1f: AUC (0-last) of TSR-022 in combination with TSR-042 and docetaxel [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1g: AUC (0-last) of TSR-022 in combination with TSR-042, pemetrexed and cisplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1h: AUC (0-last) of TSR-022 in combination with TSR-042, pemetrexed and carboplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 2: AUC (0-last) of TSR-022 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1a: Clearance (CL) of TSR-022 as monotherapy [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1b: CL of TSR-022 in combination with nivolumab [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1c: CL of TSR-022 in combination with TSR-042 [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1d: CL of TSR-022 in combination with TSR-042 and TSR-033 [Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose] [Designated as safety issue: ]

Part 1e: CL of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1f: CL of TSR-022 in combination with TSR-042 and docetaxel [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1g: CL of TSR-022 in combination with TSR-042, pemetrexed and cisplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1h: CL of TSR-022 in combination with TSR-042, pemetrexed and carboplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 2: CL of TSR-022 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1a: Volume of distribution (Vz) of TSR-022 as monotherapy [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1b: Vz of TSR-022 and in combination with nivolumab [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1c: Vz of TSR-022 in combination with TSR-042 [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1d: Vz of TSR-022 in combination with TSR-042 and TSR-033 [Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose] [Designated as safety issue: ]

Part 1e : Vz of TSR-022 in combination with TSR-042 in participants not previously treated with anti-PD-(L)1 therapy [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1f: Vz of TSR-022 in combination with TSR-042 and docetaxel [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1g: Vz of TSR-022 in combination with TSR-042, pemetrexed and cisplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1h: Vz of TSR-022 in combination with TSR-042, pemetrexed and carboplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 2: Vz of TSR-022 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1a: Terminal half life (1/2) TSR-022 as monotherapy [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1b: t1/2 of TSR-022 and in combination with nivolumab [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1c: t1/2 TSR-022 in combination with TSR-042 [Time Frame: Pre-dose, 0.25, 0.5, 1.5, 3, 24, 48, 96, 168, 336 hours post dose] [Designated as safety issue: ]

Part 1d: t1/2 TSR-022 in combination with TSR-042 and TSR-033 [Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.5, 3, 24, 48, 96, 168,336 hours post dose] [Designated as safety issue: ]

Part 1e: t1/2 TSR-022 in combination with TSR-042 in participants not previously treated with PD-(L)1 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1f: t1/2 of TSR-022 in combination with TSR-042 and docetaxel [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1g: t1/2 of TSR-022 in combination with TSR-042, pemetrexed and cisplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 1h: t1/2 of TSR-022 in combination with TSR-042, pemetrexed and carboplatin [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Part 2: t1/2 of TSR-022 [Time Frame: Pre-dose, 0.25, 0.5 hour post dose] [Designated as safety issue: ]

Estimated Enrollment: 369
Study Start Date: July 2016
Estimated Study Completion Date: June 2024
Estimated Primary Completion Date: June 2023
Arms Assigned Interventions

Experimental:Part 1a: TSR-022 monotherapy

Drug:TSR-022
TSR-022 will be administered.

Experimental:Part 1b: TSR-022 in combination with nivolumab

Drug:Nivolumab
Nivolumab will be administered.

Experimental:Part 1c: TSR-022 in combination with TSR-042

Drug:TSR-042
TSR-042 will be administered.

Experimental:Part 1d: TSR-022 in combination with TSR-042 and TSR-033

Drug:TSR-033
TSR-033 will be administered.

Experimental:Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1)

Experimental:Part 1f: TSR-022 in combination with TSR-042 and Docetaxel

Drug:Docetaxel
Docetaxel will be administered.

Experimental:Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin.

Drug:Cisplatin

Experimental:Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin.

Drug:Carboplatin

Experimental:Part 2: Cohort A Melanoma-TSR-022 as monotherapy

Experimental:Part 2: Cohort A Melanoma-TSR-022 with TSR-042

Experimental:Part2:CohortB Non-small cell lung cancer-TSR-022-monotherapy

Experimental:Part2:CohortB Non-small cell lung cancer-TSR-022 with TSR-042

Experimental:Part2:CohortC Colorectal cancer-TSR-022 as monotherapy

Experimental:Part2:CohortC Colorectal cancer-TSR-022 with TSR-042

Experimental:Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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 - 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02817633

Locations

  • United States, Arizona
    • GSK Investigational Site Goodyear, Arizona, United States, 85338
    • GSK Investigational Site Phoenix, Arizona, United States, 85054
    • GSK Investigational Site Scottsdale, Arizona, United States, 85258
    • GSK Investigational Site Tucson, Arizona, United States, 85704
    • GSK Investigational Site Tucson, Arizona, United States, 85711
  • United States, California
    • GSK Investigational Site Encinitas, California, United States, 92024
    • GSK Investigational Site Fountain Valley, California, United States, 92708
    • GSK Investigational Site Los Angeles, California, United States, 90024
    • GSK Investigational Site Los Angeles, California, United States, 90025
    • GSK Investigational Site San Marcos, California, United States, 92069
    • GSK Investigational Site Whittier, California, United States, 90606
  • United States, Colorado
    • GSK Investigational Site Aurora, Colorado, United States, 80012
    • GSK Investigational Site Aurora, Colorado, United States, 80045
    • GSK Investigational Site Denver, Colorado, United States, 80218
    • GSK Investigational Site Denver, Colorado, United States, 80218
  • United States, Connecticut
    • GSK Investigational Site New Haven, Connecticut, United States, 06511
  • United States, District of Columbia
    • GSK Investigational Site Washington, District of Columbia, United States, 20007
  • United States, Florida
    • GSK Investigational Site Jacksonville, Florida, United States, 32224
    • GSK Investigational Site Miami Beach, Florida, United States, 33140
    • GSK Investigational Site Sarasota, Florida, United States, 34232
    • GSK Investigational Site Tampa, Florida, United States, 33612
  • United States, Georgia
    • GSK Investigational Site Atlanta, Georgia, United States, 30322
    • GSK Investigational Site Augusta, Georgia, United States, 30912
  • United States, Illinois
    • GSK Investigational Site Arlington Heights, Illinois, United States, 60005
    • GSK Investigational Site Chicago, Illinois, United States, 60637
    • GSK Investigational Site Niles, Illinois, United States, 60714
  • United States, Iowa
    • GSK Investigational Site Iowa City, Iowa, United States, 52242-1009
  • United States, Kansas
    • GSK Investigational Site Wichita, Kansas, United States, 67214
  • United States, Kentucky
    • GSK Investigational Site Louisville, Kentucky, United States, 40202
    • GSK Investigational Site Pikeville, Kentucky, United States, 41501
  • United States, Maryland
    • GSK Investigational Site Rockville, Maryland, United States, 20850
  • United States, Massachusetts
    • GSK Investigational Site Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • GSK Investigational Site Detroit, Michigan, United States, 48202
  • United States, Minnesota
    • GSK Investigational Site Rochester, Minnesota, United States, 55905
  • United States, New Jersey
    • GSK Investigational Site Hackensack, New Jersey, United States, 07601
  • United States, New Mexico
    • GSK Investigational Site Farmington, New Mexico, United States, 87401
  • United States, New York
    • GSK Investigational Site Bronx, New York, United States, 10461
    • GSK Investigational Site New York, New York, United States, 10016
  • United States, Ohio
    • GSK Investigational Site Cincinnati, Ohio, United States, 45242
    • GSK Investigational Site Cleveland, Ohio, United States, 44106
  • United States, Oregon
    • GSK Investigational Site Eugene, Oregon, United States, 97401
    • GSK Investigational Site Portland, Oregon, United States, 97213-2982
  • United States, Pennsylvania
    • GSK Investigational Site Bethlehem, Pennsylvania, United States, 18015
    • GSK Investigational Site Pittsburgh, Pennsylvania, United States, 15213-2584
  • United States, South Carolina
    • GSK Investigational Site Charleston, South Carolina, United States, 29425
    • GSK Investigational Site Greenville, South Carolina, United States, 29605
  • United States, Tennessee
    • GSK Investigational Site Nashville, Tennessee, United States, 37203
  • United States, Texas
    • GSK Investigational Site Austin, Texas, United States, 78705
    • GSK Investigational Site Dallas, Texas, United States, 75246
    • GSK Investigational Site Fort Worth, Texas, United States, 76104
    • GSK Investigational Site Houston, Texas, United States, 77030
    • GSK Investigational Site Houston, Texas, United States, 77030
    • GSK Investigational Site Longview, Texas, United States, 75601
    • GSK Investigational Site McAllen, Texas, United States, 78503-1298
    • GSK Investigational Site San Antonio, Texas, United States, 78229
    • GSK Investigational Site Temple, Texas, United States, 76508
    • GSK Investigational Site Tyler, Texas, United States, 75702
    • GSK Investigational Site Weslaco, Texas, United States, 78596
  • United States, Virginia
    • GSK Investigational Site Fairfax, Virginia, United States, 8613
  • United States, Washington
    • GSK Investigational Site Kennewick, Washington, United States, 99336
    • GSK Investigational Site Puyallup, Washington, United States, 98373
    • GSK Investigational Site Tacoma, Washington, United States, 98405
  • United States, Wisconsin
    • GSK Investigational Site Madison, Wisconsin, United States, 53792
  • Spain, Navarra
    • GSK Investigational Site Madrid, Navarra, Spain, 28027
  • Spain,
    • GSK Investigational Site Barcelona, , Spain, 08035
    • GSK Investigational Site Girona, , Spain, 17007
    • GSK Investigational Site L'Hospitalet De Llobregat, , Spain, 08908
    • GSK Investigational Site Las Palmas De Gran Canaria, , Spain, 35016
    • GSK Investigational Site Madrid, , Spain, 28040
    • GSK Investigational Site Madrid, , Spain, 28041
    • GSK Investigational Site Madrid, , Spain, 28050
    • GSK Investigational Site Málaga, , Spain, 29010
    • GSK Investigational Site Pamplona, , Spain, 31008
    • GSK Investigational Site Valencia, , Spain, 46010

Sponsors and Collaborators

Tesaro, Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02817633
Other Study ID Numbers: 4020-01-001
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Tesaro, Inc.:

TSR-022

Nivolumab

Cobolimab

Advanced solid tumors

Metastatic solid tumors

Immunotherapy

PD-1

Anti-PD-1

Colorectal cancer

Non-small cell lung cancer

Melanoma

TSR-033

TSR-042

Dostarlimab

Additional relevant MeSH terms:

Carboplatin

Docetaxel

Nivolumab

Pemetrexed

Next Steps


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ClinicalTrials.gov processed this data on July 29, 2021