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DRUG:

spartalizumab (PDR001)

i
Other names: PDR001, PDR 001, PDR-001
Company:
Novartis
Drug class:
PD1 inhibitor
Related drugs:
24d
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov)
P1, N=98, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Dec 2025 --> Mar 2026
Trial completion date
|
spartalizumab (PDR001) • DKY709
2ms
PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer (clinicaltrials.gov)
P2, N=19, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Sep 2025 --> Sep 2026
Trial completion date • Trial primary completion date
|
BRAF V600E • BRAF V600 • BRAF V600K
|
Mekinist (trametinib) • Tafinlar (dabrafenib) • spartalizumab (PDR001)
2ms
Efficacy of anti-PD1 therapy in PD1-high mRNA tumors across multiple cancer types: results from cohort 1 and cohort 2 of the phase II SOLTI-1904 ACROPOLI trial. (PubMed, ESMO Open)
PD1 mRNA may help identify immunogenic tumors across cancer types. However, the trial's early closure and exploratory nature warrant further validation. A composite biomarker strategy integrating immune and tumor-intrinsic features may improve patient selection for ICIs.
P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
spartalizumab (PDR001)
3ms
Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM (clinicaltrials.gov)
P1, N=16, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Sep 2025 --> Sep 2026
Trial completion date
|
MGMT (6-O-methylguanine-DNA methyltransferase)
|
spartalizumab (PDR001) • sabatolimab (MBG453)
3ms
New P1 trial
|
spartalizumab (PDR001)
4ms
SPARC-1: A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
P1, N=17, Active, not recruiting, Columbia University | Recruiting --> Active, not recruiting | Trial completion date: Dec 2026 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2025
Enrollment closed • Trial completion date • Trial primary completion date
|
CD4 (CD4 Molecule)
|
spartalizumab (PDR001) • Ilaris (canakinumab)
5ms
CDFF332A12101: DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies (clinicaltrials.gov)
P1, N=40, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Sep 2025 --> Mar 2026 | Trial primary completion date: Sep 2025 --> Mar 2026
Trial completion date • Trial primary completion date • IO biomarker
|
VHL (von Hippel-Lindau tumor suppressor) • SDHB (Succinate Dehydrogenase Complex Iron Sulfur Subunit B) • EPAS1 (Endothelial PAS domain protein 1) • SDHC (Succinate Dehydrogenase Complex Subunit C) • SDHD (Succinate Dehydrogenase Complex Subunit D) • SDHA (Succinate Dehydrogenase Complex Flavoprotein Subunit A) • SDHAF2 (Succinate Dehydrogenase Complex Assembly Factor 2)
|
VHL mutation
|
everolimus • spartalizumab (PDR001) • DFF332 • taminadenant (NIR178)
5ms
Focus on PD-1/PD-L1-Targeting Antibodies in Colorectal Cancer: Are There Options Beyond Dostarlimab, Nivolumab, and Pembrolizumab? A Comprehensive Review. (PubMed, Molecules)
However, a growing number of additional PD-1/PD-L1 inhibitors, including AMP-224, atezolizumab, avelumab, camrelizumab, durvalumab, envafolimab, sintilimab, spartalizumab, tislelizumab, and toripalimab, are currently under investigation, offering new possibilities for the expansion of treatment options...Additionally, it explores key challenges such as primary and acquired resistance, limited efficacy in microsatellite-stable (MSS) CRC, and the complexities of combination strategies aimed at enhancing immunotherapeutic responses. By addressing these obstacles and highlighting prospects, this review provides insights into the evolving landscape of PD-1/PD-L1-targeted therapies in CRC and their potential to improve patient outcomes.
Review • Journal
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Tyvyt (sintilimab) • Bavencio (avelumab) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • Tevimbra (tislelizumab-jsgr) • Jemperli (dostarlimab-gxly) • spartalizumab (PDR001) • Enweida (envafolimab) • AMP-224
5ms
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov)
P1, N=98, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2025 --> Dec 2025
Trial completion date • Trial primary completion date
|
spartalizumab (PDR001) • DKY709
7ms
COMBI-i: A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma (clinicaltrials.gov)
P3, N=568, Terminated, Novartis Pharmaceuticals | Completed --> Terminated; Sponsor decision
Trial termination • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
BRAF mutation • BRAF V600
|
Mekinist (trametinib) • Tafinlar (dabrafenib) • spartalizumab (PDR001)
8ms
PanCAN-SR1: A Phase 1B Study of Canakinumab, Spartalizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer (PC) Patients (clinicaltrials.gov)
P1, N=10, Completed, Pancreatic Cancer Action Network | Active, not recruiting --> Completed | Phase classification: P1b --> P1
Trial completion • Phase classification
|
gemcitabine • albumin-bound paclitaxel • spartalizumab (PDR001) • Ilaris (canakinumab)
8ms
Precision Promise: A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer (clinicaltrials.gov)
P3, N=502, Completed, Pancreatic Cancer Action Network | Active, not recruiting --> Completed | N=825 --> 502 | Trial completion date: Jun 2027 --> Feb 2025 | Trial primary completion date: Jun 2027 --> Feb 2025
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
|
gemcitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • spartalizumab (PDR001) • sirolimus • pamrevlumab (FG-3019) • racemetyrosine (SM-88) • Ilaris (canakinumab)