Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab · 9 trials · 12 indications
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.
ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), \>=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination. Responses are based on investigator assessments per RECIST 1.1 without confirmation using all available scans.
The proportion of patients with confirmed PR or CR per RECIST v1.1, assessed from the start of study treatment (defined as from first dose of pembrolizumab) for up to two years. ORR in the non-targeted, unirradiated lesion(s) as defined by CR or PR per iRECIST. Objective response will be assessed separately in all sites that are not irradiated.
The proportion of patients with absence of invasive disease in the breast and lymph nodes at the time of SOC curative-intent treatment.
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab 200 mg + Epacadostat 100 mg BID | EXPERIMENTAL | Pembrolizumab + epacadostat |
| Pembrolizumab 200 mg + placebo BID | ACTIVE_COMPARATOR | Pembrolizumab + placebo |
| Pembrolizumab + Epacadostat | EXPERIMENTAL | - |
| SoC (Sunitinib or Pazopanib) | ACTIVE_COMPARATOR | Standard of care (SoC) (sunitinib or pazopanib monotherapy). |
| Pembrolizumab | EXPERIMENTAL | - |
| EXTREME | ACTIVE_COMPARATOR | EXTREME regimen includes cetuximab + cisplatin or carboplatin + 5-fluorouracil. |
| Pembrolizumab, Radiotherapy, Axatilimab | EXPERIMENTAL | Pembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance. Radiotherapy, 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2; Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance. |
| Pembrolizumab with Radiation Therapy and Axatilimab | EXPERIMENTAL | - |
| Pembrolizumab + Chemotherapy + Epacadostat | EXPERIMENTAL | Participant received pembrolizumab 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat 100 mg tablets, orally, twice daily (BID) in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles). |
| Pembrolizumab + Chemotherapy + Placebo | EXPERIMENTAL | Participant received pembrolizumab 200 mg IV infusion, Q3W on Day 1 of each 21 day cycle for up to 35 cycles + epacadostat matching placebo tablets, orally, BID in each 21 day cycle for up to 35 cycles + platinum-doublet chemotherapy (pemetrexed 500 mg/m\^2 IV infusion, Q3W + cisplatin 75 mg/m\^2 IV infusion, Q3W or carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles followed by pemetrexed maintenance; or paclitaxel 200 mg /m\^2 IV infusion, Q3W + carboplatin 5-6 mg/mL/min IV infusion Q3W for 4 cycles). |
| Pembrolizumab + Placebo | ACTIVE_COMPARATOR | Participants received pembrolizumab 200 mg by IV infusion, Q3W starting on Day 1 of each cycle for up to 35 administrations in combination with matching placebo orally, twice daily. Placebo administration was discontinued after the implementation of protocol amendment 05. |
| pembrolizumab + itacitinib | EXPERIMENTAL | Part 1a Group A will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days. Part 1b Group A-1 and Group A-2 will evaluate the MTD or PAD of itacitinib in combination with pembrolizumab in subjects with select solid tumors. |
| pembrolizumab + INCB050465 | EXPERIMENTAL | Part 1a Group B will utilize an open-label 3+3 dose-escalation design based on observing each dose level for a period of 21 days. Part 1b Group B-1 and Group B-2 will evaluate the MTD or PAD of INCB050465 in combination with pembrolizumab in subjects with select solid tumors. Part 2 will evaluate the combination of INCB050465 in combination with pembrolizumab in subjects with small cell lung cancer, non-small lung cancer and urothelial cancer. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks. |
| Epacadostat | DRUG | Epacadostat administered orally twice daily. |
| Placebo | DRUG | Matching placebo administered orally twice daily. |
| Sunitinib | DRUG | Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle. |
| Pazopanib | DRUG | Pazopanib 800 mg administered orally once daily. |
| Cetuximab | DRUG | Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week. |
| Cisplatin | DRUG | Cisplatin administered intravenously every 3 weeks for \</= 6 cycles. |
| Carboplatin | DRUG | Carboplatin administered intravenously every 3 weeks for \</= 6 cycles. |
| 5-Fluorouracil | DRUG | 5-Fluorouracil administered intravenously every 3 weeks for \</= 6 cycles. |
| Radiotherapy | RADIATION | RT, 8 Gy x 3 fractions over 3 consecutive days at C1D8/Week 2; |
| Axatilimab | DRUG | Axatilimab (SNDX-6352; INCA034176), 1 mg/kg, IV, Q2W starting 1 week post- RT C1D15/Week 3 until disease progression or treatment intolerance. |
| Radiation Therapy | RADIATION | Radiation therapy (RT) consists of 8 Gy for 3 fractions over 3 consecutive days at Week 2. |
| Platinum-based chemotherapy | DRUG | Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology. |
| itacitinib | DRUG | Itacitinib tablets administered orally once daily. |
| INCB050465 | DRUG | INCB050465 tablets administered orally once daily. |
Inclusion Criteria: * Histologically-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type. * Progression or recurrence of urothelial carcinoma following ...