Study of NIS793 (with and without spartalizumab) in combination with standard of care chemotherapy in previously untreated metastatic pancreatic cancer patients

Phase 1

• Conditions: Pancreatic ductal adenocarcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000349-14-IT
• Lead Sponsor: OVARTIS PHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-22
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

Participants with histologically or cytologically confirmed treatment naïve metastatic adenocarcinoma of the pancreas with measurable disease per RECIST 1.1.
Participants must have a site of disease amenable to biopsy, be candidate for tumor biopsy, and must be willing to undergo a tumor biopsy at screening and during therapy on the study.
ECOG performance status = 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 94

Exclusion Criteria

Previous radiotherapy, surgery (note: placement of biliary stent is allowed), chemotherapy or investigational therapy for the treatment of metastatic disease. Participants having received previous chemotherapy in the adjuvant setting
Participants with MSI-H pancreatic adenocarcinoma
Participants with a diagnosis of pancreatic neuroendocrine tumors (NETs), acinar, or islet cell tumors
Participants amenable to potentially curative resection
Presence of symptomatic CNS metastases or CNS metastases that require local CNS-directed therapy
History of severe hypersensitivity reactions to other monoclonal antibodies
Malignant disease other than that being treated in the study
Systemic chronic steroid therapy (>10mg/day prednisone or equivalent) or any immunosuppressive therapy
Known history of testing positive for HIV infection
Active HBV and HCV infection
Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment
Active, known or suspected autoimmune disease
History of or current pneumonitis or interstitial lung disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified