Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-3795 · 2 trials · 14 indications
ORR was defined as the percentage of participants in the analysis population who have a best confirmed response of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR was assessed by independent review committee (ICR) for the primary analysis.
MTD of MK-3795 will be determined. MTD will be defined as the dose level at which 2 or more participants experience a dose limiting toxicity (DLT) which will be deemed intolerable and the dose level below will be declared the MTD.
The RP2D of MK-3795 will be determined. The RP2D will be determined based on the MTD (or the optimal biological dose (OBD) if the MTD is not identified), the overall safety profile with continued treatment, and pharmacokinetic (PK) profile.
| Arm | Type | Description |
|---|---|---|
| MK-3795 | EXPERIMENTAL | Participants receive 800 mg MK-3795 orally twice daily. Participants may continue to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression. |
| Part 1: MK-3795 | EXPERIMENTAL | Participants with advanced ccRCC receive MK-3795 at an initial dose level of 100mg orally, twice daily (BID) up to approximately 3 weeks. Dose levels will be escalated to identify the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) for MK-3795. Each escalated dose will be continued for up to approximately 3 weeks before escalating a dose again until a dose limiting toxicity (DLT) is experienced. Thereafter, participants receive RP2D dose of MK-3795 for up to 2 cycles (each cycle length = 28 days) for up to approximately 1 year. Participants may continue to receive MK-3795 beyond 1 year at the discretion of the Sponsor. |
| Part 2: MK-3795 + Nivolumab + Belzutifan | EXPERIMENTAL | Participants with advanced ccRCC in the expansion phase receive the RP2D of MK-3795 orally in combination with nivolumab 240mg by IV infusion over \~60 minutes every 2 weeks for up to \~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later. As per Amendment 09 (29 March 2024), participants will not receive MK-3795. Participants receive nivolumab 240mg by IV infusion over \~60 minutes every 2 weeks in combination with belzutifan 120 mg once daily (QD) for up to \~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later. If participants experience an adverse event, then nivolumab will be discontinued and participants will continue to receive belzutifan 120 mg QD alone for up to \~1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later. |
| Part 3: MK-3795 + Cabozantinib | EXPERIMENTAL | Participants with advanced ccRCC in the expansion phase receive the RP2D of MK-3795 in combination with cabozantinib 20mg up to 60mg orally QD for up to approximately 1 year (12 cycles; each cycle length = 28 days) or until unequivocal progression or treatment discontinuation, whichever occurs later. |
| Name | Type | Description |
|---|---|---|
| MK-3795 | DRUG | 800 mg twice daily (four 200 mg oral tablets twice daily) |
| Nivolumab | DRUG | IV infusion |
| Cabozantinib | DRUG | Oral administration |
| Bezlutifan | DRUG | Oral administration |
Inclusion Criteria: * Has at least 1 measurable ccRCC tumor and no solid ccRCC tumor greater than 3.0 cm, based on radiologic diagnosis (histologic diagnosis not required); may have VHL disease-associated lesions in other organ systems * Has a diagnosis of von Hippel Lindau disease, based on a germ...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Tango Therapeutics, Inc. | TNGX | 1 | PHASE1 | TNG462 |
| Adlai Nortye Ltd. Sponsored ADR | ANL | 2 | PHASE1 | AN9025, AN4035 |
| Pasithea Therapeutics Corp. | KTTA | 1 | PHASE1 | PAS-004 |
| BeOne Medicines Ltd. Sponsored ADR | ONC | 1 | PHASE1 | BG-85738, Tislelizumab |
MK-3795 is an investigational small molecule being studied for the treatment of clear cell renal cell carcinoma (ccRCC) and Von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma. It is in Phase 2 clinical development for oncology indications.
MK-3795 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The drug is an investigational small molecule in Phase 2 clinical development for oncology indications.
MK-3795 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or completed to evaluate its safety and efficacy in patients with clear cell renal cell carcinoma.
MK-3795 has been studied in clinical trials including NCT02293980, a Phase 1 dose-escalation trial in patients with advanced clear cell renal cell carcinoma, and NCT03108066, a Phase 2 trial for Von Hippel-Lindau disease-associated clear cell renal cell carcinoma.
Yes, MK-3795 is also known as PT2385. Clinical trial records refer to the drug as both MK-3795 and PT2385, including the Phase 1 trial NCT02293980 and the Phase 2 trial NCT03108066.