Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511350-41-00 | Other Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this interventional study is to determine the strength of cobolimab and dostarlimab that is most tolerated in children and young adults who have advanced solid tumors. This study also aims: (a) to check if it is safe to use cobolimab and dostarlimab combination in children and young adults, (b) to see how to manage the side effects that may occur, and (c) the effect of this treatment in participants
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1- Dose determination | Experimental |
| |
| Part 2- Dose expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cobolimab | Drug | Cobolimab will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1- Number of participants with Dose Limiting Toxicities (DLTs) | Up to 42 days | |
| Part 1- Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), immune-mediated adverse events (imAEs) and adverse events (AEs) leading to discontinuation occurring during the study | Up to approximately 46 months | |
| Part 1- Serum concentration of Cobolimab | 1±0.5 hours (h) post-dose on Cycle 1 Day 1; 168±12 h post-dose Cycle 1Day 8; Pre-dose and 1±0.5 h post-dose on Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1(Each cycle is of 21 days) | |
| Part 1- Serum concentration of Dostarlimab | 1±0.5 h post start of cobolimab infusion on Cycle 1 Day 1; Pre-dose on Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1(Each cycle is of 21 days) | |
| Part 1- Recommended Phase 2 Dose (RP2D) of Cobolimab and Dostarlimab combination | Up to approximately 12 months | |
| Part 2- Confirmed Objective Response Rate (ORR) | Confirmed ORR is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR), evaluated using disease-specific tumor assessment criteria based on Investigator assessment | Up to approximately 46 months |
| Part 2- Number of participants with TEAEs, SAEs, imAEs, TEAEs leading to death and AEs leading to discontinuation | Up to approximately 46 months | |
| Part 2-Number of participants with changes in laboratory parameters, vital signs and cardiac parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and 2: Receptor occupancy (RO) | RO will be measured in whole blood and presented as normalized ratio [Fluorescence Minus One (FMO) subtracted values of free T cell immunoglobulin and mucin domain containing protein 3 (TIM-3) to total TIM-3] | Pre-dose Cycle 1 Day 1, 5 h post-start of cobolimab administration Cycle 1 Day 1, anytime Cycle 1 Day 8, pre-dose Cycle 2 Day 1, and pre-dose Cycle 4 Day 1 (Each cycle is of 21 days) |
Not provided
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Part 1: Participants with advanced or metastatic solid tumors who have had disease progression after treatment with available therapies that are known to confer clinical benefit and who have limited available treatment options as determined by the investigator. Additionally, exposure to prior immunotherapy or experimental therapies is acceptable:
Part 2:
Participants with Melanoma who have not received prior systemic therapy:
Relapsed/refractory Hodgkin lymphoma (HL) that has failed at least 2 prior lines of systemic therapy)
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Medical conditions:
Prior/ Concomitant therapy:
Prior/Concurrent clinical study experience
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Los Angeles | California | 90048 | United States | ||
| GSK Investigational Site |
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/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Dostarlimab | Drug | Dostarlimab will be administered |
|
| Up to approximately 46 months |
| Part 1- Confirmed ORR | Confirmed ORR is defined as the proportion of participants who have achieved confirmed CR or confirmed PR, evaluated using disease specific tumor assessment criteria based on Investigator assessment | Up to approximately 70 months |
| Part 1 and 2: Progression Free Survival (PFS) | PFS is defined as the length of time until disease progression, from the date of first dose to the earliest date of assessment of disease progression based on disease-specific tumor assessment criteria by Investigator assessment, or death by any cause, whichever occurs first | Up to approximately 70 months |
| Part 1 and 2: Duration of response (DOR) | DOR is defined as the time from first documented response (CR/PR) until the time of first documentation of disease progression based on disease-specific tumor assessment criteria by Investigator assessment, or death, whichever occurs first | Up to approximately 70 months |
| Part 1 and 2: Overall Survival (OS) | OS is defined as the time from the date of first dose to the date of death by any cause | Up to approximately 70 months |
| Part 1 and 2: Number of participants with positive results in Anti-drug antibody (ADA) test against Cobolimab | Pre-dose on Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1[Each cycle is of 21 days]; 30-Day and 90-Day safety follow up (FUP) Visit |
| Part 1 and 2: Number of participants with positive results in Anti-drug antibody (ADA) test against Dostarlimab | Pre-dose on Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1[Each cycle is of 21 days]; 30-Day and 90-Day safety follow up (FUP) Visit |
| Part 1 and 2: Titers of ADA to Cobolimab | Pre-dose on Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1[Each cycle is of 21 days]; 30-Day and 90-Day safety follow up (FUP) Visit |
| Part 1 and 2: Titers of ADA to Dostarlimab | Pre-dose on Cycle 1 Day 1; Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1[Each cycle is of 21 days]; 30-Day and 90-Day safety follow up (FUP) Visit |
| Part 2- Serum concentration of Cobolimab | 1±0.5 hours(h) post-dose on Cycle1Day 1;168±12h post-dose Cycle1Day8; Pre-dose & 1±0.5h post-dose on Cycle2Day1; Cycle4Day1 & Cycle6Day1[Each cycle is of 21 days];End of Treatment(EOT; EOT is within 7days of last dose), 30Day safety follow up(FUP) Visit |
| Part 2- Serum concentration of Dostarlimab | 1±0.5 h post start of cobolimab infusion on Cycle 1 Day 1; Pre-dose on Cycle 2 Day 1; Cycle 4 Day 1 and Cycle 6 Day 1 [Each cycle is of 21 days]; End of Treatment (EOT; EOT is within 7 days of last dose), 30-Day safety follow up (FUP) Visit |
| Iowa City |
| Iowa |
| 52242 |
| United States |
| GSK Investigational Site | Hackensack | New Jersey | 07601 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45229 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02903 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Brno | 61300 | Czechia |
| GSK Investigational Site | Phaha 5 | 15006 | Czechia |
| GSK Investigational Site | Copenhagen | 2100 | Denmark |
| GSK Investigational Site | Bordeaux | 33076 | France |
| GSK Investigational Site | Lyon | 69373 | France |
| GSK Investigational Site | Paris | 75248 | France |
| GSK Investigational Site | Strasbourg | 67098 | France |
| GSK Investigational Site | Villejuif | 94805 | France |
| GSK Investigational Site | Bologna | 40138 | Italy |
| GSK Investigational Site | Naples | 80123 | Italy |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Madrid | 28009 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D006689 | Hodgkin Disease |
| D005909 | Glioblastoma |
| D000080443 | Diffuse Intrinsic Pontine Glioma |
| D004806 | Ependymoma |
| D012516 | Osteosarcoma |
| D006528 | Carcinoma, Hepatocellular |
| D018197 | Hepatoblastoma |
| C537258 | Fibrolamellar hepatocellular carcinoma |
| D012208 | Rhabdomyosarcoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D009375 | Neoplasms, Glandular and Epithelial |
| D020295 | Brain Stem Neoplasms |
| D015192 | Infratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D018193 | Neoplasms, Complex and Mixed |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C000719628 | dostarlimab |
Not provided
Not provided
Not provided