Pancreas CancerPhase 1NCT05417386
FOLFIRINOX + NIS793 in Pancreatic Cancer
A Phase 1 study testing FOLFIRINOX, Oxaliplatin and Leucovorin in people with Pancreas Cancer and Metastatic Pancreatic Cancer, run by Colin D. Weekes, M.D., PhD at 1 site in United States.
Trial summary
This research is being done to evaluate the safety and effectiveness of the drug NIS793 in combination with the standard of care treatment FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin), chemoradiation and surgery for people with metastatic pancreas adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- FOLFIRINOX, Oxaliplatin and Leucovorin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2022to 10 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Safety Run-in Cohort: Histologically confirmed metastatic pancreatic adenocarcinoma without prior therapy for pancreatic adenocarcinoma.
- Phase 1B Cohort: Histologically confirmed locally advanced disease (borderline resectable or locally advanced pancreatic adenocarcinoma) or poorly differentiated adenosquamous carcinoma includes both borderline resectable or locally advanced disease. Patients with localized pancreas adenocarcinoma cannot have received any prior therapy for borderline resectable or locally advanced pancreas adenocarcinoma
- Borderline Resectable Disease: Defined by the NCCN as tumors with venous involvement of the SMV/portal vein demonstrated tumor abutment with or without impingement and narrowing of the lumen, either tumor thrombus or encasement but with suitable vessel proximal and distal to the area of vessel involvement, allowing for safe resection or reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; or tumor abutment of the SMA not to exceed greater than 180 degrees of the circumference of the vessel wall.Tumors involving retroperitoneal structures that can be surgically removed (i.e.kidney), will also be included.
- Locally Advanced Pancreas Adenocarcinoma: Defined by the NCCN as: Tumors of the head that have greater than 180 degrees of SMA encasement or any celiac abutment, unreconstructable SMV or portal occlusion, or aortic invasion or encasement. Tumors of the body with SMA or celiac encasement of greater than 180 degrees, unreconstructable SMV or portal occlusion, or aortic invasion. Tumors of the tail with SMA or celiac encasement of greater than 180 degrees. Irrespective of location, all tumors with evidence of nodal metastasis outside of the resection field are deemed unresectable. Participants must have measurable disease, defined as at least one lesion that measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
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- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,500/mcL
- Platelets ≥100,000/mcL
- Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) if no biliary stenting has been done OR 2.0 x ULN if patient is status post biliary stenting or two downward trending values.
- AST(SGOT)/ALT(SGPT) Safety Run-in Metastatic Disease: < 5 x institutional ULN. Locally advanced disease: ≤3 × institutional ULN
- Creatinine ≤ institutional ULN OR
- Glomerular filtration rate (GFR) no lower than 60 mL/min/1.73 m2
- Creatinine clearance for males = (140 - age [yrs]) (body wt [kg]) / (72) (serum creatinine [mg/dL])
- Creatinine clearance for females = 0.85 x male value
- Human immunodeficiency virus (HIV)-infected participants on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Additionally, participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
- To be eligible for this trial, participants should be class. To be eligible for study participation, participants must be class 2 B or better.
- The effects of treatment on the developing human fetus are unknown. For this reason, all patients of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 9 months after completion of mFOLFIRINOX or NIS793 administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Metastatic Disease Safety Run-in: Any prior chemotherapy, radiation therapy, immunotherapy, biologic ('targeted') therapy or investigational therapy for pancreas adenocarcinoma.
- Locally Advanced Disease Cohort: Any prior chemotherapy, radiation therapy, immunotherapy, biologic ('targeted') therapy or investigational therapy for treatment of the patient's pancreatic tumor.
- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
- Patients with deficient mismatch/microsatellite unstable or high tumor mutation burden cancers.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
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- Patients requiring use of steroids to treat active uncontrolled brain metastases will be excluded from study enrollment. Patients treated with radiation > 4 weeks prior with follow up imaging showing control are eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to NIS793, 5-fluorouracil, irinotecan and oxaliplatin not amenable to institutional chemotherapy desensitization protocol.
- Known, existing uncontrolled coagulopathy. Concomitant treatment with full dose warfarin (coumadin) is NOT allowed. Patients may receive low molecular weight heparin (LMWH) (such as enoxaparin and dalteparin) and direct oral anticoagulant (DOAC) for management of deep venous thrombosis (DVT).
- History of bleeding diathesis or recent major bleeding events (i.e. Grade > 2 bleeding events in the month prior to treatment).
- Concomitant use of cimetidine, as it can decrease clearance of 5FU. Another H2- blocker or proton pump inhibitor may be substituted before study entry.
- Patient with cardiac ventricular arrhythmias requiring antiarrhythmic therapy, or atrioventricular heart block (due to 5FU administration)
- Participants with uncontrolled intercurrent illness or infection.
- Participants with uncontrolled seizures, central nervous system disorders or psychiatric illness/social situations that would limit compliance with study requirements.
- Has received a live vaccine within 30 days of planned start of study therapy. Note:
- Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. COVID non-live vaccines are allowed.
- History of severe hypersensitivity reaction to any monoclonal antibody.
- Patient with known history of UGT1A1 gene polymorphism, Patient with known history of UGT1A1 gene polymorphism.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
Official title: A Phase IB Study FOLFIRINOX and NIS793 in Patients With Pancreatic Cancer
This research is being done to evaluate the safety and effectiveness of the drug NIS793 in combination with the standard of care treatment FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin), chemoradiation and surgery for people with metastatic pancreas adenocarcinoma.
The drugs involved in this study are:
- NIS793
- FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin)
Other interventions include
- chemoradiation
- surgery.
Read the detailed description
This is a two part Phase 1B study investigating whether NIS793 improves the clinical benefit of FOLFIRINOX treatment for metastatic pancreas adenocarcinoma.The first part is a safety run-in using a dose escalation strategy to determine the recommended phase 2 dose of the drug NIS793. In the second part participants will be a randomized assigned to receive either FOLFIRINOX plus NIS793 or FOLFIRINOX alone.
NIS793 binds to the protein that can be found on tumor cells, called TGFβ, thereby preventing its role in cancer metastasis (spreading). FOLFIRINOX is a combination of 4 chemotherapy drugs that may help shrink tumors.
The U.S. Food and Drug Administration (FDA) has not approved NIS793 as a treatment for any disease.
The FDA has approved FOLFIRINOX as a treatment option for metastatic pancreas adenocarcinoma The FDA has not approved the combination of NIS793 and FOLFIRINOX as a treatment for any disease.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
It is expected that about 50 people will take part in this research study.
Novartis, a pharmaceutical company, is supporting this research study by providing funding for the study, including the study drug.
- Being tested
- FOLFIRINOX, Oxaliplatin, Leucovorin, Irinotecan, 5-Fluorouracil (5-FU)
- Keywords
- Pancreas Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRINOXDrug
Also called 5FU, leucovorin, irinotecan, oxaliplatin
Combination of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin given by intravenous infusion
OxaliplatinDrug
Also called Eloxatin
Part of the FOLFIRINOX drug combination, given by intravenous infusion
LeucovorinDrug
Also called Calcium Leucovorin, Citrovorum Factor, Folinic Acid
Part of the FOLFIRINOX drug combination, given by intravenous infusion
IrinotecanDrug
Also called Camptosar, Camptothecin-11, CPT-1
Part of the FOLFIRINOX drug combination, given by intravenous infusion
5-Fluorouracil (5-FU)Drug
Also called Adrucil
Part of the FOLFIRINOX drug combination, given by intravenous infusion
NIS793Drug
Also called Nisevokitug
Given by intravenous infusion
ChemoradiationRadiation
Combination of Chemo (Capecitabine) and Radiation Therapy
CapecitabineDrug
Also called Xeloda
Taken Orally as part of Chemoradiation
Radiation TherapyRadiation
Radiation Therapy as part of Chemoradiation
SurgeryProcedure or surgery
Surgical removal of tumor
| Study group | Role | What they receive |
|---|---|---|
| Safety Run-In | Experimental | Following a 3 + 3 dose escalation design 6-18 participants will receive NIS793 and FOLFIRINOX on day 1 of each 14 day cycle for 3+ cycles until recommended phase 2 dose is determined. Receives: Drug: FOLFIRINOX; Drug: NIS793 |
| FOLFIRINOX | Experimental | Participants will be randomly assigned to receive:
* FOLFIRINOX on day 1 of each 14 day cycle for cycles 1-8
* Cycles 9+: Chemoradiation (CRT) and surgery Receives: Drug: FOLFIRINOX; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-Fluorouracil (5-FU); Radiation: Chemoradiation; Drug: Capecitabine; Radiation: Radiation Therapy; Procedure: Surgery |
| FOLFIRINOX + NIS793 | Experimental | Participants will be randomly assigned to receive:
* FOLFIRINOX FOLFIRINOX + NIS793 on day 1 of each 14 day cycle for cycles 1-8
* Cycles 9+: Chemoradiation (CRT) with NIS793, Surgery, NIS793 Receives: Drug: FOLFIRINOX; Drug: Oxaliplatin; Drug: Leucovorin; Drug: Irinotecan; Drug: 5-Fluorouracil (5-FU); Drug: NIS793; Radiation: Chemoradiation; Drug: Capecitabine; Radiation: Radiation Therapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Run In-Recommended Phase 2 dose (RP2D)
Primary endpoint of safety run-in cohort is to define the recommended phase 2 dose as analyzed by 2-dimensional imaging (Computed Tomography, CT) or MRI utilizing Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), obtained at 4-cycle therapy intervals.
Measured: Up to 2 months after baseline
R0 Resection Rate
The primary endpoint of the two-arm non-comparative phase IB study (Part 2) is to estimate the R0 resection rate associated with the FOLFIRINOX/NIS793 therapy administered as neoadjuvant therapy.
Measured: Up to 8 months after baseline
Secondary outcomes (5)
Disease-Free Survival (DFS)
Defined as the time from time of surgical resection of pancreas tumor to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.
Measured: Up to approximately 6 years after baseline
Progression-free survival (PFS)
Defined from the date of randomization or registration to the earliest date of progressive disease or death due to any cause. Progressive disease must be documented objectively in one or more local and/or distant sites. PFS will be censored at the date of last follow-up for patients alive without documented progression.
PFS curves will be estimated by the Kaplan-Meier method and compared using the logrank test.
Measured: Up to approximately 6 years after baseline
Overall survival (OS)
Defined as date of randomization or registration to the date of death due to any cause and censored at the date of last follow-up for patients still alive. OS curves will be estimated by the Kaplan-Meier method and compared using the log-rank test.
Measured: Up to approximately 6 years after baseline
Pathologic complete response (pCR)
Defined as no residual cancer in the pancreatic tissue at surgical resection. The pCR rate will be reported among all eligible patients as well as among resected patients with 95% confidence intervals based on the exact binomial distribution. Comparisons between arms may be assessed using Fisher's exact test.
Measured: up to 8 months after baseline
Resection rate
Percentage of patient who undergo resection of their primary tumor, regardless of microscopic location of residual tumor to location of the resection margin.
Measured: up to 8 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start9 Aug 2022
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Why it stopped: NIS793 is no longer being developed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colin D. Weekes, M.D., PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Colin D. Weekes, M.D., PhD, Massachusetts General Hospital
- Investigators
- Colin D Weekes, MD, PHD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417386
- Sponsor's protocol ID
- 22-082
- Status last verified
- Nov 2025
- First submitted
- 7 Jun 2022
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB Study FOLFIRINOX and NIS793 in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05417386
- Acronym / sponsor ID
- 22-082
- Keywords
- Pancreas Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NIS793 is no longer being developed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Colin D. Weekes, M.D., PhDUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to evaluate the safety and effectiveness of the drug NIS793 in combination with the standard of care treatment FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin), chemoradiation and surgery for people with metastatic pancreas adenocarcinoma.
The drugs involved in this study are:
- NIS793
- FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin)
Other interventions include
- chemoradiation
- surgery.
Detailed description
This is a two part Phase 1B study investigating whether NIS793 improves the clinical benefit of FOLFIRINOX treatment for metastatic pancreas adenocarcinoma.The first part is a safety run-in using a dose escalation strategy to determine the recommended phase 2 dose of the drug NIS793. In the second part participants will be a randomized assigned to receive either FOLFIRINOX plus NIS793 or FOLFIRINOX alone.
NIS793 binds to the protein that can be found on tumor cells, called TGFβ, thereby preventing its role in cancer metastasis (spreading). FOLFIRINOX is a combination of 4 chemotherapy drugs that may help shrink tumors.
The U.S. Food and Drug Administration (FDA) has not approved NIS793 as a treatment for any disease.
The FDA has approved FOLFIRINOX as a treatment option for metastatic pancreas adenocarcinoma The FDA has not approved the combination of NIS793 and FOLFIRINOX as a treatment for any disease.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
It is expected that about 50 people will take part in this research study.
Novartis, a pharmaceutical company, is supporting this research study by providing funding for the study, including the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safety Run-In | Experimental | Drug: FOLFIRINOX, Drug: NIS793Following a 3 + 3 dose escalation design 6-18 participants will receive NIS793 and FOLFIRINOX on day 1 of each 14 day cycle for 3+ cycles until recommended phase 2 dose is determined. |
| FOLFIRINOX | Experimental | Drug: FOLFIRINOX, Drug: Oxaliplatin, Drug: Leucovorin, Drug: Irinotecan, Drug: 5-Fluorouracil (5-FU), Radiation: Chemoradiation, Drug: Capecitabine, Radiation: Radiation Therapy, Procedure: SurgeryParticipants will be randomly assigned to receive: * FOLFIRINOX on day 1 of each 14 day cycle for cycles 1-8 * Cycles 9+: Chemoradiation (CRT) and surgery |
| FOLFIRINOX + NIS793 | Experimental | Drug: FOLFIRINOX, Drug: Oxaliplatin, Drug: Leucovorin, Drug: Irinotecan, Drug: 5-Fluorouracil (5-FU), Drug: NIS793, Radiation: Chemoradiation, Drug: Capecitabine, Radiation: Radiation Therapy, Procedure: SurgeryParticipants will be randomly assigned to receive: * FOLFIRINOX FOLFIRINOX + NIS793 on day 1 of each 14 day cycle for cycles 1-8 * Cycles 9+: Chemoradiation (CRT) with NIS793, Surgery, NIS793 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Safety Run-in Cohort: Histologically confirmed metastatic pancreatic adenocarcinoma without prior therapy for pancreatic adenocarcinoma.
- Phase 1B Cohort: Histologically confirmed locally advanced disease (borderline resectable or locally advanced pancreatic adenocarcinoma) or poorly differentiated adenosquamous carcinoma includes both borderline resectable or locally advanced disease. Patients with localized pancreas adenocarcinoma cannot have received any prior therapy for borderline resectable or locally advanced pancreas adenocarcinoma
- Borderline Resectable Disease: Defined by the NCCN as tumors with venous involvement of the SMV/portal vein demonstrated tumor abutment with or without impingement and narrowing of the lumen, either tumor thrombus or encasement but with suitable vessel proximal and distal to the area of vessel involvement, allowing for safe resection or reconstruction; gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to the celiac axis; or tumor abutment of the SMA not to exceed greater than 180 degrees of the circumference of the vessel wall.Tumors involving retroperitoneal structures that can be surgically removed (i.e.kidney), will also be included.
- Locally Advanced Pancreas Adenocarcinoma: Defined by the NCCN as: Tumors of the head that have greater than 180 degrees of SMA encasement or any celiac abutment, unreconstructable SMV or portal occlusion, or aortic invasion or encasement. Tumors of the body with SMA or celiac encasement of greater than 180 degrees, unreconstructable SMV or portal occlusion, or aortic invasion. Tumors of the tail with SMA or celiac encasement of greater than 180 degrees. Irrespective of location, all tumors with evidence of nodal metastasis outside of the resection field are deemed unresectable. Participants must have measurable disease, defined as at least one lesion that measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
- Age ≥18 years.
Key exclusion criteria (18 listed)
- Metastatic Disease Safety Run-in: Any prior chemotherapy, radiation therapy, immunotherapy, biologic ('targeted') therapy or investigational therapy for pancreas adenocarcinoma.
- Locally Advanced Disease Cohort: Any prior chemotherapy, radiation therapy, immunotherapy, biologic ('targeted') therapy or investigational therapy for treatment of the patient's pancreatic tumor.
- Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery
- Patients with deficient mismatch/microsatellite unstable or high tumor mutation burden cancers.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFIRINOXAlso: 5FU, leucovorin, irinotecan, oxaliplatinCombination of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin given by intravenous infusion | Drug | FOLFIRINOX, FOLFIRINOX + NIS793, Safety Run-In |
| OxaliplatinAlso: EloxatinPart of the FOLFIRINOX drug combination, given by intravenous infusion | Drug | FOLFIRINOX, FOLFIRINOX + NIS793 |
| LeucovorinAlso: Calcium Leucovorin, Citrovorum Factor, Folinic AcidPart of the FOLFIRINOX drug combination, given by intravenous infusion | Drug | FOLFIRINOX, FOLFIRINOX + NIS793 |
| IrinotecanAlso: Camptosar, Camptothecin-11, CPT-1Part of the FOLFIRINOX drug combination, given by intravenous infusion | Drug | FOLFIRINOX, FOLFIRINOX + NIS793 |
| 5-Fluorouracil (5-FU)Also: AdrucilPart of the FOLFIRINOX drug combination, given by intravenous infusion | Drug | FOLFIRINOX, FOLFIRINOX + NIS793 |
| NIS793Also: NisevokitugGiven by intravenous infusion | Drug | FOLFIRINOX + NIS793, Safety Run-In |
| ChemoradiationCombination of Chemo (Capecitabine) and Radiation Therapy | Radiation | FOLFIRINOX, FOLFIRINOX + NIS793 |
| CapecitabineAlso: XelodaTaken Orally as part of Chemoradiation | Drug | FOLFIRINOX, FOLFIRINOX + NIS793 |
| Radiation TherapyRadiation Therapy as part of Chemoradiation | Radiation | FOLFIRINOX, FOLFIRINOX + NIS793 |
| SurgerySurgical removal of tumor | Procedure or surgery | FOLFIRINOX, FOLFIRINOX + NIS793 |
Primary outcome
Safety Run In-Recommended Phase 2 dose (RP2D)
Time frame: Up to 2 months after baseline
Primary endpoint of safety run-in cohort is to define the recommended phase 2 dose as analyzed by 2-dimensional imaging (Computed Tomography, CT) or MRI utilizing Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), obtained at 4-cycle therapy intervals.
R0 Resection Rate
Time frame: Up to 8 months after baseline
The primary endpoint of the two-arm non-comparative phase IB study (Part 2) is to estimate the R0 resection rate associated with the FOLFIRINOX/NIS793 therapy administered as neoadjuvant therapy.
5 secondary outcomes
Disease-Free Survival (DFS)
Time frame: Up to approximately 6 years after baseline
Progression-free survival (PFS)
Time frame: Up to approximately 6 years after baseline
Overall survival (OS)
Time frame: Up to approximately 6 years after baseline
Pathologic complete response (pCR)
Time frame: up to 8 months after baseline
Resection rate
Time frame: up to 8 months after baseline
Results and safety
The study was stopped early (reason given: NIS793 is no longer being developed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin D Weekes, MD, PHD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FOLFIRINOX, Oxaliplatin and Leucovorin in people with Pancreas Cancer and Metastatic Pancreatic Cancer, run by Colin D. Weekes, M.D., PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: NIS793 is no longer being developed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Run In-Recommended Phase 2 dose (RP2D) (time frame: Up to 2 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.