Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03484923 | Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma | PHASE2 | COMPLETED | 196 | — | — | Sep 10, 2018 | Dec 30, 2022 | Jun 18, 2024 | 30 | United States, Australia +8 |
| NCT02404441 | Phase I/II Study of PDR001 in Patients With Advanced Malignancies | PHASE1 | COMPLETED | 319 | — | — | Apr 27, 2015 | Jul 21, 2020 | Aug 3, 2022 | 41 | United States, Canada +12 |
ORR defined as the percentage of patients with a best overall response of either confirmed complete response (CR) or partial response (PR) as per local review by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and assessed by computed tomography (CT)/ magnetic resonance imaging (MRI). CR:Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Estimated the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) for PDR001. AUC0-336h is the AUC from time zero to 336 hour post dose of a measurable concentration sampling time.
DLT is defined as an adverse event (AE) or abnormal laboratory value of common terminology criteria for adverse events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications, which occurs within the first cycle of treatment with PDR001 during the dose escalation part of the study for which relationship to study treatment cannot be ruled out, with some exceptions.
ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 CR = at least 2 determinations of CR at least 4 weeks apart before progression where confirmation required or 1 determination of CR prior to progression where confirmation not required. PR = at least 2 determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) where confirmation required or 1 determination of PR prior to progression where confirmation not required. RECIST criteria is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
| Arm | Type | Description |
|---|---|---|
| Arm 1: LAG525 + PDR001 (randomized section) | EXPERIMENTAL | Participnats randomized to receive LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks |
| Arm 2: INC280+PDR001 (randomized section) | EXPERIMENTAL | Participants randomized to receive INC280 orally at a dosage of 400 mg twice daily, in combination with PDR001 intravenously at a dosage of 400 mg every 4 weeks |
| Arm 3: ACZ885 + PDR001 (randomized section) | EXPERIMENTAL | Participants randomized to receive to receive ACZ885 at a dosage of 300 mg administered subcutaneously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks |
| Arm 4: LEE011 + PDR001 (randomized section) | EXPERIMENTAL | Participants randomized to receive LEE011 orally at a dosage of 600 mg once daily on Days 1-21 of a 28-day cycle, in combination with PDR001 intravenously at a dosage of 400 mg every 4 weeks |
| Arm 1A: LAG525 + PDR001 (non-randomized section) | EXPERIMENTAL | LAG-3 positive participants received LAG525 at a dosage of 600 mg administered intravenously every 4 weeks, in combination with PDR001 at a dosage of 400 mg administered intravenously every 4 weeks |
| patients with solid tumors | OTHER | Phase I Dose escalation cohorts |
| Selected tumor types | OTHER | Phase II expansion: Selected tumor types: melanoma, NSCLC, triple negative breast cancer, anaplastic thyroid cancer |
| Name | Type | Description |
|---|---|---|
| PDR001 | DRUG | 400 mg of PDR001 administered every 4 weeks intravenously |
| LAG525 | DRUG | 600 mg of LAG525 administered every 4 weeks intravenously |
| INC280 | DRUG | 400 mg of INC280 administered twice daily orally |
| ACZ885 | DRUG | 200 mg of ACZ885 administered every 4 weeks subcutaneosuly |
| LEE011 | DRUG | 600 mg of LEE011 orally taken once daily on Days 1-21 of a 28-day cycle |
Key inclusion criteria for Arm 1, 2, 3, 4: * Histologically confirmed unresectable or metastatic stage IIIB/C/D or IV melanoma using AJCC edition 8. * Previously treated for unresectable or metastatic melanoma: * Subjects with V600BRAF wild-type disease had to have received prior systemic therap...