spartalizumab (PDR001) / Novartis - LARVOL DELTA

DKY709A12101C: Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=320 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer

DKY709A12101C: 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 | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2026 ➔ Oct 2026 | Trial primary completion date: Mar 2026 ➔ Oct 2026

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: 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 | Sponsor: Novartis Pharmaceuticals | Trial completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: 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 | Sponsor: Novartis Pharmaceuticals | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: 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 | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2025 ➔ Sep 2025 | Trial primary completion date: May 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: 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 | Sponsor: Novartis Pharmaceuticals | Trial completion date: Feb 2025 ➔ May 2025 | Trial primary completion date: Feb 2025 ➔ May 2025

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: 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 | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: May 2025 ➔ Dec 2024

Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: 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 | Sponsor: Novartis Pharmaceuticals | Trial completion date: Dec 2024 ➔ May 2025 | Trial primary completion date: Dec 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: 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 | Sponsor: Novartis Pharmaceuticals | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Sep 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: 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 | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2025 ➔ Sep 2024 | Trial primary completion date: May 2025 ➔ Sep 2024

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: 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 | Sponsor: Novartis Pharmaceuticals | Trial completion date: Apr 2024 ➔ May 2025 | Trial primary completion date: Apr 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=99 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2025 ➔ Mar 2024 | Trial primary completion date: May 2025 ➔ Mar 2024

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=99 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2024 ➔ May 2025 | Trial primary completion date: Mar 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=99 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: May 2025 ➔ Mar 2024 | Trial primary completion date: May 2025 ➔ Mar 2024

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=99 | Active, not recruiting | Sponsor: Novartis Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=380 ➔ 99

Enrollment change • Enrollment closed • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=380 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Apr 2024 ➔ May 2025 | Trial primary completion date: Apr 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=380 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Apr 2023 ➔ Apr 2024 | Trial primary completion date: Apr 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=320 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Nov 2022 ➔ Apr 2023 | Trial primary completion date: Nov 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

DKY709A12101C: Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=320 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Colorectal Cancer • Cutaneous Melanoma • Gastrointestinal Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • Triple Negative Breast Cancer

Clinical activity of tislelizumab in PD1 mRNA high advanced solid tumors: SOLTI-1904 ACROPOLI phase II trial (ESMO 2026) - P2 | "In the phase II ACROPOLI trial, prior cohorts evaluating spartalizumab suggested that high PD1 mRNA expression may identify immunogenic tumors across cancer types (Seguí et al. Among patients with germinal center-containing TLS (n=11, 23.0%), ORR was 55% (6/11) and CBR was 73% (8/11). Treatment-related adverse events were mostly grade 1-2, with only two serious TRAEs reported (myasthenia/myositis/myocarditis; adrenal insufficiency).Conclusions Tislelizumab showed activity in PD1 mRNA high advanced solid tumors across cancer types, with exploratory signals of increased activity in tumors with mature TLS."

Clinical • IO biomarker • Metastases • P2 data • Colorectal Cancer • Oncology • Sarcoma • Solid Tumor • PD-1

A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab (clinicaltrials.gov) - P1 | N=68 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Cutaneous Melanoma • Hematological Malignancies • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Oncology

A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer (clinicaltrials.gov) - P1 | N=280 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • DUSP6

A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab (clinicaltrials.gov) - P1 | N=68 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Melanoma • Hematological Malignancies • Lung Cancer • Lymphoma • Melanoma • Non Small Cell Lung Cancer • Oncology

ACROPOLI: Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors (clinicaltrials.gov) - P2 | N=73 | Active, not recruiting | Sponsor: SOLTI Breast Cancer Research Group | Recruiting ➔ Active, not recruiting | N=141 ➔ 73

Enrollment change • Enrollment closed • Anal Carcinoma • Biliary Cancer • Breast Cancer • Carcinosarcoma • Cervical Cancer • Cholangiocarcinoma • Clear Cell Carcinoma • Colorectal Adenocarcinoma • Colorectal Cancer • Endocrine Cancer • Epithelial Ovarian Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Eye Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Melanoma • Mesothelioma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Adenocarcinoma • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer • Uveal Melanoma • PD-1

ACROPOLI: Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients with PD1-high MRNA Expressing Tumors (clinicaltrials.gov) - P2 | N=141 | Not yet recruiting | Sponsor: SOLTI Breast Cancer Research Group

New P2 trial • Anal Carcinoma • Biliary Cancer • Breast Cancer • Carcinosarcoma • Cervical Cancer • Cholangiocarcinoma • Clear Cell Carcinoma • Colorectal Adenocarcinoma • Colorectal Cancer • Epithelial Ovarian Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Eye Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Melanoma • Mesothelioma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Adenocarcinoma • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma • Triple Negative Breast Cancer • Urothelial Cancer • Uterine Cancer • Uveal Melanoma • PD-1