A Phase II Trial of INCMGA00012 in Patients With Previously Treated Unresectable or Metastatic Adenosquamous Pancreatic or Ampullary Cancer

Who is this study for? Patients with previously treated unresectable or metastatic adenosquamous pancreatic or ampullary cancer
What treatments are being studied? INCMGA00012
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Phase 2 study to evaluate the clinical activity of INCMGA00012 in patients with Unresectable or metastatic Adenosquamous Pancreatic or Ampullary Cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years.

• Have histologically or cytologically - proven adenosquamous carcinoma of the pancreas or ampulla.

• Has unresectable or metastatic measurable disease.

• Has received (or been intolerant to or ineligible for) at least 1 prior line of cytotoxic chemotherapy and received no more than 2 prior systemic treatments.

• Presence of at least one lesion with measurable disease.

• Accept to have a tumor biopsy of an accessible lesion at baseline and on treatment.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• If HIV-positive, then all of the following criteria must also be met: cluster of differentiation (CD) 4+ count ≥ 350/μL, undetectable viral load, and receiving highly active antiretroviral therapy.

• Life expectancy of greater than 3 months.

• Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.

• Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.

• Men must use acceptable form of birth control while on study.

• Ability to understand and willingness to sign a written informed consent document.

Locations
United States
Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore
Time Frame
Start Date: 2020-04-09
Completion Date: 2024-12-03
Participants
Target number of participants: 25
Treatments
Experimental: INCMGA00012 (PD-1 antibody)
All participants received the interventional study drug; INCMGA00012.
Related Therapeutic Areas
Sponsors
Collaborators: Incyte Corporation, National Cancer Institute (NCI)
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.