Immune Checkpoint Inhibitor M7824 and the Immunocytokine M9241 in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Advanced Pancreas Cancer
TerminatedPhase 1, PHASE2Results postedLast updated 18 May 2022
What this trial tests
Phase 1, PHASE2 trial testing M7824 in Histologically or Cytologically Confirmed Pancreatic Cancer in 3 participants. Terminated before completion.
18 and older, any sex, with Histologically or Cytologically Confirmed Pancreatic Cancer or Unresectable or Borderline Resectable Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS) for All ParticipantsSecondary· Time interval from start to treatment to disease progression, an average of 4 months.
Progression free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in target lesions and/or the appearance of new lesions.
Progression-free Survival (PFS) for Participants Who Did Not Undergo Surgical ResectionSecondary· time interval from start of treatment to documented evidence of disease progression
Progression free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Progression was measured using the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in target lesions and/or the appearance of new lesions.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).Secondary· Date treatment consent signed to date off study, approximately 4 months and 13 days.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent
Number of Participants With a Dose-limiting Toxicity (DLT)Secondary· First 28 days of treatment
A DLT is any Grade ≥ 3 adverse events occurring during the first 28 days of treatment except adverse events unrelated, or unlikely related to study agents and probably or definitely related to other causes.
Time frame: Date treatment consent signed to date off study, approximately 4 months and 13 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
Fewer than 10 percent of people with pancreas cancer can have surgery. Surgery gives the best outcome. Radiation therapy is usually used to make surgery possible. But it does not work for most people. Adding immunotherapy might help.
Objective:
To find a safe combined dose of Bintrafusp Alfa (M7824), NHS-IL12 (M9241, and radiation and to see if it causes pancreas cancer tumors to shrink.
Eligibility:
People ages 18 and older who have pancreas cancer and cannot have curative surgery
Design:
Participants will be screened under protocol 01-C-0129 with:
Medical history
Physical exam
Heart, urine, and blood tests
Scans. For this, participants will lie in a machine that takes pictures of the body. They may receive a contrast agent by vein.
Possible tumor biopsy
Participants will take the study drugs either alone or with radiation. They will get M7824 by vein every 2 weeks. They will get M9241 injected under the skin every 4 weeks. Participants who get radiation will get it 5 days in a row the first month.
Participants will have visits every 2 weeks. They will repeat screening tests.
If participants tumors shrink, they will have surgery. If their whole tumor is removed, they will stop treatment. They will otherwise continue treatment as long as they can tolerate it and it is helping them.
Participants will have visits 1 week and 1 month after they stop treatment. Then they will be contacted by phone or email for life. If they stop treatment for a reason other than their disease getting worse, they will have scans every 12 weeks.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04296942 — BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)
· Phase 1
· terminated
NCT04633252 — A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01AD
· Phase 1, PHASE2
· recruiting
NCT04417660 — Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma
· Phase 2
· active not recruiting
NCT04574583 — Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Com
· Phase 1, PHASE2
· completed
NCT04551950 — Bintrafusp Alfa Combination Therapy in Participants With Cervical Cancer (INTR@PID 046)
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 18 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04327986.