Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma
ConditionPancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGulam Manji
About this trial
The purpose of this study is to combine standard radiation therapy with drugs that encourages the body's immune system against cancer cells and simultaneously adding drugs which also target the pathway that the tumor uses to evade the immune system (CD73 and A2a/b). The study hopes that these drugs will work in concert with radiation therapy to kill cancer cells.
The specific goal of this study is to ensure that treatment with zimberelimab and stereotactic body radiation therapy (SBRT) alone or in combination with quemliclustat (a drug which blocks CD73), with or without etrumadenant (a drug which blocks the A2a/b) given before surgery is safe and if it can further increase the immune response against the tumor.
Eligibility criteria
Qualifiers
Histological or pathological confirmation of pancreatic adenocarcinoma Cytologic or histologic proof of pancreatic ductal adenocarcinoma (PDAC) needs to be verified by the treating institution pathologist. A pathological report from non-treating institutions is sufficient to consent and to initiate investigational therapy if tissue sample is unavailable for evaluation at time of consent or enrollment. However, in such a case, PDAC diagnosis should be confirmed by the treating institution pathologist at a later time.
Completed 8 cycles of neoadjuvant modified FOLFIRINOX. Omission of oxaliplatin due to adverse events may be allowed in cycles 5-8 with consultation with the principal investigator.
Patients with surgically resectable PDAC who are considered appropriate to undergo the applicable operation.
Eligible to undergo SBRT.
Disqualifiers
Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
Patients who are receiving any other investigational agents concurrently.
Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable).
Uncontrolled pleural effusion, pericardial effusion, or ascites.
Trial design
Treatments tested in this trial
- Stereotactic body radiotherapy (SBRT)
- Zimberelimab
- Quemliclustat
- Etrumadenant
- Modified FOLFIRINOX
Treatment groups
60 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov