Umbrella Study of Sasanlimab Combined With Targeted Therapies in Participants With Non Small Cell Lung Cancer

A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined With Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants With Non-Small Cell Lung Cancer (NSCLC)

Sponsoren

Hauptsponsor: Pfizer

Quelle Pfizer
Kurze Zusammenfassung

Phase 1b/Phase 2 open-label, multi-center, parallel group umbrella study. Sasanlimab (a PD-1 antagonist monoclonal antibody) will be combined with a different targeted therapy in each sub-study. The Phase1b part of each sub-study will evaluate the safety of the combination and select the dose for the Phase 2 part. The Phase 2 part of each sub-study will evaluate the anti-tumor activity of the combination.

Gesamtstatus Not yet recruiting
Anfangsdatum October 22, 2020
Fertigstellungstermin November 27, 2024
Primäres Abschlussdatum November 27, 2024
Phase Phase 1/Phase 2
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Percentage of participants with Dose-limiting toxicities (DLT) First dose (Cycle 1 Day 1) to end of first treatment cycle (about 21-28 days)
Durable Objective Response Rate - Percentage of Participants With Objective Response First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days
Sekundäres Ergebnis
Messen Zeitfenster
Number of participants with Treatment-Emergent Adverse Events First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days
Percentage of participants with Treatment-Emergent Adverse Events First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days
Number of Participants with Treatment-Emergent Laboratory Abnormalities First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days
Percentage of Participants with Treatment-Emergent Laboratory Abnormalities First dose (Cycle 1 Day 1) to 30 days after last dose (up to about 24 months); each cycle is about 28 days
Durable Objective Response Rate - Percentage of Participants With Objective Response First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days
Objective Response Rate-Percentage of Participants with Objective Response First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months); each cycle is about 28 days
Duration of Response (DR) First objective response to progressive disease or death (up to about 24 months); each cycle is about 28 days
Time to Tumor Response (TTR) First dose (Cycle 1 Day 1) up to first objective response. Each cycle is about 28 days
Progression-Free Survival (PFS) First dose (Cycle 1 Day 1) to progressive disease or death (up to about 24 months). Each cycle is about 28 days
Overall Survival First dose (Cycle 1 Day 1) to death (up to about 40 months); each cycle is about 28 days
Incidence of Anti-Drug Antibody (ADA) for sasanlimab First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months); each cycle is about 28 days
Neutalizing antibody (NAb) titers for sasanlimab First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months); each cycle is about 28 days
Correlation between Objective Response and PD-L1 expression at baseline First dose (Cycle 1 Day 1) to End of Study Treatment (up to about 24 months); each cycle is about 28 days
PK Parameter AUC (Area Under the Curve) First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months). Day 1, 8, and 15 of Cycle 1. Day 1 of Cycle 2 and 3. Days 1 and 8 of Cycle 5. Day 1 of Cycles 7, 10, 13, and then every 6 cycles until EOT. Each cycle is about 28 days
PK Parameter Ctrough First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months). Day 1, 8, and 15 of Cycle 1. Day 1 of Cycle 2 and 3. Days 1 and 8 of Cycle 5. Day 1 of Cycles 7, 10, 13, and then every 6 cycles until EOT. Each cycle is about 28 days
PK Parameter Cmax (Maximum Observed Plasma Concentration) First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months). Day 1, 8, and 15 of Cycle 1. Day 1 of Cycle 2 and 3. Days 1 and 8 of Cycle 5. Day 1 of Cycles 7, 10, 13, and then every 6 cycles until EOT. Each cycle is about 28 days
PK Parameter Tmax (Time to Reach Maximum Observed Plasma Concentration) First dose (Cycle 1 Day 1) to End of Treatment (up to about 24 months). Day 1, 8, and 15 of Cycle 1. Day 1 of Cycle 2 and 3. Days 1 and 8 of Cycle 5. Day 1 of Cycles 7, 10, 13, and then every 6 cycles until EOT. Each cycle is about 28 days
Einschreibung 375
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Sasanlimab Prefillled syringe

Beschreibung: prefilled syringe

Armgruppenetikett: Sub-Study A

Interventionsart: Drug

Interventionsname: Encorafenib

Beschreibung: capsules

Armgruppenetikett: Sub-Study A

Interventionsart: Drug

Interventionsname: Binimetinib

Beschreibung: tablets

Armgruppenetikett: Sub-Study A

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria Umbrella Phase 1b & 2: - Histologically or cytologically confirmed locally advanced/metastatic (Stage IIIB-IV) NSCLC. - At least one measurable lesion per RECIST v1.1 at Screening. - ECOG Performance Status 0 or 1. - Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1. - Adequate hepatic, renal, and bone marrow function. Additional Inclusion Criteria for Sub-Study A Phase 1b &2: -BRAFV600E mutation in tumor tissue or plasma as determined by a local laboratory PCR or NGS assay and documented in a local pathology report. Additional Inclusion Criteria for Sub-Study A Phase 1b only: -Any line of therapy for locally advanced/metastatic NSCLC. Additional Inclusion Criteria for Sub-Study A Phase 2 only: -Previously untreated for locally advanced/metastatic NSCLC Exclusion Criteria Umbrella Phase 1b &2: - Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent. - Active, non-infectious pneumonitis, pulmonary fibrosis, or known history of immune-mediated pneumonitis. - Active infection requiring systemic therapy. - Clinically significant cardiovascular disease. - Other malignancy within 2 years of first dose, with exceptions. - Symptomatic brain metastasis, with exceptions. Additional Exclusion Criteria for Sub-Study A Phase 1b &2: - EGFR mutation, ALK fusion oncogene, or ROS1 rearrangement. - Prior treatment with any BRAF inhibitor or MEK inhibitor. Additional Exclusion Criteria for Sub-Study A Phase 2 only: -Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Pfizer CT.gov Call Center Study Director Pfizer
Gesamtkontakt

Nachname: Pfizer CT.gov Call Center

Telefon: 1-800-718-1021

Email: [email protected]

Ort
Einrichtung: California Cancer Associates for Research and Excellence, Inc (cCARE)
Standort Länder

United States

Überprüfungsdatum

October 2020

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: Sub-Study A

Art: Experimental

Beschreibung: Sasanlimab will be administered subcutaneously. Encorafenib & binimetinib will be administered orally. Treatments will be administered until progressive disease, unacceptable AE, participant withdraws, or study is terminated.

Patientendaten Yes
Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov