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Also known as MK-7684
vibostolimab · 1 trial · 1 indication
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE4.0).
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
| Arm | Type | Description |
|---|---|---|
| vibostolimab | EXPERIMENTAL | During an initial dose evaluation phase, participants will receive Dose A, B, C, D, E, or F of vibostolimab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD has been established. The RPTD will be established based on the number of dose limiting toxicities (DLTs) at each dose level. Once the RPTD is established, participants will continue receiving the RPTD of vibostolimab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached. |
| vibostolimab + pembrolizumab | EXPERIMENTAL | During an initial dose evaluation phase, participants will receive Dose A, B, C, D, E, or F of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle (for a maximum of 35 cycles) until the RPTD of vibostolimab has been established. The RPTD will be established based on the number of DLTs at each dose level. Once the RPTD of vibostolimab is established, participants will continue receiving the RPTD of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached. |
| Advanced solid tumor cohort | EXPERIMENTAL | Participants will receive the RPTD of vibostolimab monotherapy or the RPTD of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached. |
| Randomized dose 1 comparison cohort | EXPERIMENTAL | Participants will be randomized to receive a fixed dose (Dose 1) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached. |
| Randomized dose 2 comparison cohort | EXPERIMENTAL | Participants will be randomized to receive a fixed dose (Dose 2) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached. |
| vibostolimab +pembrolizumab+pemetrexed+carboplatin | EXPERIMENTAL | Participants will receive a fixed dose of vibostolimab in combination with 200 mg pembrolizumab, 500 mg/m\^2 pemetrexed, and Area Under Curve (AUC) 5 mg/mL/min carboplatin on Day 1 of each 21-day infusion cycle for up to 4 cycles followed by maintenance therapy with a fixed dose of vibostolimab in combination with 200 mg pembrolizumab and 500 mg/m\^2 pemetrexed on Day 1 of each 21-day infusion cycle for up to an additional 31 cycles. |
| vibostolimab Dose 1 Japanese cohort | EXPERIMENTAL | Japanese participants will be randomized to receive a fixed dose (Dose 1) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached. |
| vibostolimab Dose 2 Japanese cohort | EXPERIMENTAL | Japanese participants will be randomized to receive a fixed dose (Dose 2) of vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day infusion cycle until the 35-cycle limit is reached. |
| pembrolizumab/vibostolimab coformulation | EXPERIMENTAL | Participants will receive a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles. |
| vibostolimab+pembrolizumab+carboplatin OR cisplatin+etoposide | EXPERIMENTAL | Participants will receive 200 mg vibostolimab in combination with 200 mg pembrolizumab, plus the investigator's choice of Area Under Curve (AUC) 5 mg/mL/min carboplatin OR 75 mg/m\^2 cisplatin on Day 1 of each 21-day cycle plus 100 mg/m\^2/day etoposide on Days 1-3 of each 21-day cycle for up to 4 cycles. Maintenance therapy with 200 mg vibostolimab in combination with 200 mg pembrolizumab on Day 1 of each 21-day cycle will continue for up to an additional 31 cycles. A participant will be allowed to switch from cisplatin to carboplatin in the event of an adverse event (AE), ineligibility for further cisplatin therapy, and/or the investigator considers switching to carboplatin to be in the best interest of the participant. |
| pembrolizumab/vibostolimab coformulation China cohort | EXPERIMENTAL | Participants from mainland China will receive a fixed dose of pembrolizumab/vibostolimab coformulation, consisting of 200 mg of pembrolizumab + 200 mg vibostolimab, on Day 1 of each 21-day infusion cycle for up to 35 cycles. |
| Name | Type | Description |
|---|---|---|
| vibostolimab | BIOLOGICAL | Administered as an intravenous (IV) infusion on Day 1 of 21-day infusion Cycles 1-35 |
| pembrolizumab | BIOLOGICAL | Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-35 |
| pemetrexed | DRUG | Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-35 |
| carboplatin | DRUG | Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-4 |
| pembrolizumab/vibostolimab coformulation | BIOLOGICAL | Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-35 |
| cisplatin | DRUG | Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-4 |
| etoposide | DRUG | Administered as an IV infusion on Days 1-3 of 21-day infusion Cycles 1-4 |
Inclusion Criteria: * For Part A participants enrolled prior to Amendment 7, must have a histologically or cytologically confirmed metastatic solid tumor for which there is no available therapy that is expected to convey clinical benefit * For Part A Japanese cohort added with Amendment 7: Must res...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Momelotinib |
| Eli Lilly and Company | LLY | 2 | PHASE1 | LY3410738, LY5830966 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 2 | PHASE2 | GB2064, DMR-001 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE1 | Revumenib |
Vibostolimab is an investigational biologic developed by Merck & Company, Inc. (MRK) for the treatment of neoplasms, specifically advanced solid tumors. It is an antagonist that targets TIGIT and has been studied both as a single agent and in combination with pembrolizumab in a Phase 1 clinical trial.
Vibostolimab targets TIGIT and acts as an antagonist. By binding TIGIT, it is designed to interfere with that receptor's signaling. It has been evaluated in oncology as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors.
Vibostolimab is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 1 study of vibostolimab alone and in combination with pembrolizumab in advanced solid tumors, designated MK-7684-001 and KEYVIBE-001.
Vibostolimab is in Phase 1 clinical development and is investigational. Its single listed trial, NCT02964013, is a completed Phase 1 study. The program has not advanced beyond Phase 1 in the available record, and vibostolimab is not described as an approved therapy.
Vibostolimab has been studied in NCT02964013, titled Study of Vibostolimab Alone and in Combination With Pembrolizumab in Advanced Solid Tumors (MK-7684-001) (KEYVIBE-001). This completed Phase 1 trial enrolled 474 participants aged 18 years and older with neoplasms and used a controlled design.