Borderline Resectable, Locally Advanced or Metastatic Pancreatic CancerPhase 1/2LAPTOPNCT04247165
Nivolumab, Ipilimumab and Chemoradiation in Pancreatic Cancer.
A Phase 1/2 study testing Gemcitabine, Nab-paclitaxel and Nivolumab in people with Borderline Resectable, Locally Advanced or Metastatic Pancreatic Cancer, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) remains a dreadful disease due to its often advanced stage at diagnosis and poor sensitivity to chemotherapy. A locally unresectable tumor (locally advanced pancreatic cancer (LAPC)) is present in 30% of the cases and is defined as a surgically unresectable tumor encasing the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Resectable, Locally Advanced or Metastatic Pancreatic Cancer
- What is being tested?
- Gemcitabine, Nab-paclitaxel and Nivolumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Jun 2020to 5 Dec 2024
- Phase
- Phase 1/2
- 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
- Signed informed consent
- Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study
- Histological or cytological confirmation of locally advanced or metastatic pancreatic carcinoma prior to entering this study
- No prior chemotherapy regimens received for PC
- Age 18 years or older
Show all 18Show fewer
- Life expectancy greater than 6 months
- ECOG/WHO Performance Status (PS) 0-1
- All participants will be required to undergo mandatory pre- and on-treatment biopsies at acceptable clinical risk as judged by the investigator. An archival pre-treatment sample is acceptable
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
- Platelet count ≥ 100 x 10⁹/L
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol/L)
- AST/ALT ≤ 5 x ULN
- Serum creatinine ≤ 1.5 x ULN or CrCl ≥ 40 mL/min (using the Cockcroft-Gault formula)
- Women of child bearing potential (WOCBP) must use method(s) of contraception as indicated in Appendix 3. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 30 days plus the time required for the investigational drug to undergo five half-lives. The half-life of nivolumab and ipilimumab is up to 25 days and 18 days, respectively. WOCBP should therefore use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year (Appendix 3). The investigator shall review contraception methods and the time period that contraception must be followed. Men that are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half-lives. The half-life of nivolumab is up to 25 days. Men who are sexually active with WOCBP must continue contraception for 31 weeks (90 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception
- Subjects must have signed and dated a BIOPAC approved written informed consent form in accordance with regulatory and institutional guidelines
Who cannot join
- Metastatic disease
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
- Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Patients should be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
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- Allergies and adverse drug reaction
- History of allergy to study drug components
- History of severe hypersensitivity reaction to any monoclonal antibody
- WOCBP who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LAPTOP: Phase 1/2 Study in Borderline Resectable, Locally Advanced or Metastatic Pancreatic Cancer to Assess Safety and Potential Efficacy of Dual Checkpoint Inhibition in Combination with Gemcitabine and Nab-paclitaxel Followed by Immune-chemoradiation.
Pancreatic ductal adenocarcinoma (PDAC) remains a dreadful disease due to its often advanced stage at diagnosis and poor sensitivity to chemotherapy. A locally unresectable tumor (locally advanced pancreatic cancer (LAPC)) is present in 30% of the cases and is defined as a surgically unresectable tumor encasing the adjacent arteries [celiac axis, superior mesenteric artery (SMA)]. In these patients, chemotherapy has been the standard treatment for decades, optionally combined with radiotherapy. Patients with borderline resectable pancreatic cancer (BRPC) comprise a group of patients with PDAC who are at a high risk of having positive margins if upfront resection is pursued. In addition, multiple studies have reported these patients have increased probability of early recurrence of local and systemic disease resulting in poorer outcomes. Although some patients are treated with an aggressive surgery-first approach and adjuvant systemic therapies, a preoperative chemotherapy and/or chemoradiation approach is becoming more common for all patients with BRPC, and this strategy is adapted in Danish and international guidelines. Majority of patients present with metastatic pancreatic cancer (mPC). Therapy options are limited by chemotherapy in palliative setting. The superiority of the FOLFIRINOX regimen demonstrated in the phase III mPC setting led many centers to investigate FOLFIRINOX with or without chemoradiotherapy in patients with LAPC tumor. Gemcitabine combined with nab-paclitaxel is the approved first-line treatment for patients with advanced PC. This regimen showed a median progression-free survival (PFS) of 5.5 months and a median overall survival (OS) of 8.5 months and is the predominantly used regimen in metastatic PC. The role of radiation therapy in the management of nonresectable PC remains controversial. The results of small randomized trials comparing chemoradiotherapy with chemotherapy of patients with LAPC are divergent.
Immunotherapy has emerged as a therapeutic approach that offers effective and durable treatment options for subsets of patients with various types of cancer. However, these successes have not manifested similar benefits for PDAC patients mostly due to a lack of pre-existing T-cell immunity and/or a highly immunosuppressive tumor microenvironment (TME). Considering the emerging role of the TME, the combination of checkpoint blocking antibodies with agents that target the inhibitory effects of the TME could lead to better responses in tumor historically resistant to checkpoint blocking antibody approaches. For example, in heavily pretreated patients with advanced/metastatic PDAC, preliminary data from the phase 2 study CHECKPAC (NCT02866383) showed that checkpoint inhibition in combination with stereotactic body radiotherapy (SBRT) provided durable clinical benefit in a small proportion of patients, including prolonged, sustained partial responses. Furthermore, the addition of standard-of-care chemotherapy could further potentiate the anti-tumor effects of immunotherapy approaches by reducing the tumor burden, exposing antigens, and directly affecting the immunosuppressive TME compartment.
To explore the safety and synergy of the proposed combinatorial approach, participants with borderline resectable, locally advanced or mPC will receive nivolumab and ipilimumab administered in combination with gemcitabine and nab-paclitaxel followed by immune-chemoradiation.
Read the detailed description
Patients receive nivolumab and ipilimumab. Nivolumab 3 mg/kg will be given on Day 1 (± 3 days) of each 28-day treatment cycle. Ipilimumab 1 mg/kg will be given only on day 1 in cycle 1. Nivolumab will be administered as an IV infusion over 30 (± 5) minutes and then, after a 30 minutes rest period, ipilimumab will be administered as an IV infusion over 30 (± 5) minutes.
Pre-medication for chemotherapy (based on standard-of-care and local institutional standards) and chemotherapy will then be administered after a further 30 minutes rest period. The recommended dose of nab-paclitaxel is 100 mg/m2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8, and 15 of each 28-day cycle. Gemcitabine 800 mg/m2 will be adminestered over 30 to 40 minutes immediately after nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
At the beginning of cycle 3, patients also undergo concurrent MRI-guided adaptive SBRT (8 Gy x 3 fractions) delivered by ViewRay MR-Linear Accelerator.
Cycles repeats every 4 weeks for 4 courses (16 weeks) in the absence of disease progression, unacceptable toxicity, withdrawal of consent, or study closure.
Once 4 cycles of study treatment have been completed, subjects without disease progression or unacceptable toxicity may continue as per Investigator's Choice to either:
- Continuation of treatment with nivolumab, nab-paclitaxel and gemcitabine or surgery. Nivolumab can be continued until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or up to 12 cycles in total. Patients will receive chemotherapy until PD, unacceptable toxicity or withdrawal of consent, according to investigator's judgment
- If tumor response allows for surgical intervention, the subject will be eligible for that treatment as deemed appropriate by the investigators. Surgical intervention may not occur prior to completing the planned 4 cycles of nivolumab, nab-paclitaxel, gemcitabine and SBRT regardless the patient demonstrates a major response to therapy. Patients after PC resection will receive treatment until recurrence, unacceptable toxicity, withdrawal of consent, clear clinical deterioration, or for a maximum of 6 cycles, according to investigator's judgment Patients who discontinue without PD (stable disease (SD), partial response (PR), or complete response (CR)) will have both the safety follow-up period and survival follow-up period to occur simultaneously during the 2-year follow-up period. The duration of this follow-up is up to 2 years following the last dose of study treatment, although a longer follow-up period could be considered in selected cases if an efficacy signal is apparent. Patients will receive follow-up CT/MRI scans every 2 months (±14 days) until documented progression of disease, withdrawal of consent from active participation in the study, lost to follow-up, or for at least 2 years after start of treatment, whichever is earliest. Tumor evaluations will be assessed by the investigators and response to be determined according to response evaluation criteria in solid tumors (RECIST) v1.1 guidelines. Tumor assessment scans, for participants who have ongoing clinical benefit beyond the 2-year period from start of treatment, may continue to be collected as part of standard-of-care treatment. Subsequent therapies will also be recorded in this survival follow-up period.
All subjects who discontinue treatment for any reason will have a safety follow-up visit about 30, 60 and 100 days after treatment discontinuation and will be followed for OS and post-study anticancer therapies approximately every 90 days by phone or review of medical records until death, withdrawal of consent, or lost to follow-up.
To minimize the risks of adding or nivolumab + ipilimumab followed by nivolumab and chemo-radiation, safety will be monitored by a Bayesian stopping rule for the rate of treatment-related AEs leading to discontinuation greater than 30% (summarized baseline toxicity rate). For example, if 3 patients out of the first 6 or 4 out of the first 7 evaluable patients experience treatment-related AEs leading to discontinuation, accrual to the trial will be temporarily suspended and the principle investigator and study team will review the toxicity data and recommend either modification or termination of the trial.
- Being tested
- Gemcitabine, Nab-paclitaxel, Nivolumab, Ipilimumab, SBRT
- Keywords
- pancreatic cancer, borderline resectable, locally advanced or metastatic pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
800 mg/m2 Day 1, 8, 15: Q4W IV Infusion
Nab-paclitaxelDrug
Also called Abraxane®
100 mg/m2 Day 1, 8, 15: Q4W IV Infusion
NivolumabDrug
Also called Opdivo®
3 mg/kg Day 1, Q4W IV Infusion
IpilimumabDrug
Also called Yervoy®
1 mg/kg Day 1 Cycle 1 IV Infusion
SBRTRadiation
Patients will be planned and treated with SBRT on a MRidian MR guided Linac.
Prescription dose shall be according to the following specifications:
- Prescription dose shall be according to the following specifications:
- A total dose of 24 Gy in 3 fractions (3 fractions/week) are prescribed as the mean dose to the PTV.
- Pauses are accepted but the treatment should be delivered within 10 calendar days.
- PTV should be covered by 95% isodose (PTV D99% >95%).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Nivolumab 3 mg/kg will be given on day 1 (± 2 days) of each 28-day treatment cycle until the progression of disease, discontinuation due to toxicity, withdrawal of consent. Ipilimumab 1 mg/kg will be given once only on day 1 cycle 1. Nivolumab will be administered as an IV infusion over 30 (± 5) minutes and then, after a 30 minutes rest period, ipilimumab will be administered as an IV infusion over 30 (± 5) minutes. Pre-medication for chemotherapy (based on standard-of-care and local institutional standards) and chemotherapy will then be administered after a further 30 minutes rest period.
The recommended dose of nab-paclitaxel is 100 mg/m2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8, and 15 of each 28-day cycle. Gemcitabine 800 mg/m2 will be administered over 30 to 40 minutes immediately after nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Drug: Nivolumab; Drug: Ipilimumab; Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related AEs, SAEs, AEs leading to discontinuation, death, and laboratory abnormalities
Measured: 12 months
Secondary outcomes (4)
Median PFS using RECIST v1.1
Measured: 12 months
Median OS
Measured: 24 months
Objective Response Rate (ORR) by RECIST v1.1
Measured: 12 months
Rate of downstaging to surgical resection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start2 Jun 2020
- Primary completion24 May 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Resectable, Locally Advanced or Metastatic Pancreatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inna Chen, MD, Herlev Hospital
- Investigators
- Inna M Chen, MD, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247165
- Sponsor's protocol ID
- GI 1931
- Acronym
- LAPTOP
- Status last verified
- May 2024
- First submitted
- 25 Jan 2020
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LAPTOP: Phase 1/2 Study in Borderline Resectable, Locally Advanced or Metastatic Pancreatic Cancer to Assess Safety and Potential Efficacy of Dual Checkpoint Inhibition in Combination with Gemcitabine and Nab-paclitaxel Followed by Immune-chemoradiation.
- ClinicalTrials.gov ID
- NCT04247165
- Acronym / sponsor ID
- LAPTOP / GI 1931
- Keywords
- pancreatic cancer, borderline resectable, locally advanced or metastatic pancreatic cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 29 Jan 2020 (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.
Pancreatic ductal adenocarcinoma (PDAC) remains a dreadful disease due to its often advanced stage at diagnosis and poor sensitivity to chemotherapy. A locally unresectable tumor (locally advanced pancreatic cancer (LAPC)) is present in 30% of the cases and is defined as a surgically unresectable tumor encasing the adjacent arteries [celiac axis, superior mesenteric artery (SMA)]. In these patients, chemotherapy has been the standard treatment for decades, optionally combined with radiotherapy. Patients with borderline resectable pancreatic cancer (BRPC) comprise a group of patients with PDAC who are at a high risk of having positive margins if upfront resection is pursued. In addition, multiple studies have reported these patients have increased probability of early recurrence of local and systemic disease resulting in poorer outcomes. Although some patients are treated with an aggressive surgery-first approach and adjuvant systemic therapies, a preoperative chemotherapy and/or chemoradiation approach is becoming more common for all patients with BRPC, and this strategy is adapted in Danish and international guidelines. Majority of patients present with metastatic pancreatic cancer (mPC). Therapy options are limited by chemotherapy in palliative setting. The superiority of the FOLFIRINOX regimen demonstrated in the phase III mPC setting led many centers to investigate FOLFIRINOX with or without chemoradiotherapy in patients with LAPC tumor. Gemcitabine combined with nab-paclitaxel is the approved first-line treatment for patients with advanced PC. This regimen showed a median progression-free survival (PFS) of 5.5 months and a median overall survival (OS) of 8.5 months and is the predominantly used regimen in metastatic PC. The role of radiation therapy in the management of nonresectable PC remains controversial. The results of small randomized trials comparing chemoradiotherapy with chemotherapy of patients with LAPC are divergent.
Immunotherapy has emerged as a therapeutic approach that offers effective and durable treatment options for subsets of patients with various types of cancer. However, these successes have not manifested similar benefits for PDAC patients mostly due to a lack of pre-existing T-cell immunity and/or a highly immunosuppressive tumor microenvironment (TME). Considering the emerging role of the TME, the combination of checkpoint blocking antibodies with agents that target the inhibitory effects of the TME could lead to better responses in tumor historically resistant to checkpoint blocking antibody approaches. For example, in heavily pretreated patients with advanced/metastatic PDAC, preliminary data from the phase 2 study CHECKPAC (NCT02866383) showed that checkpoint inhibition in combination with stereotactic body radiotherapy (SBRT) provided durable clinical benefit in a small proportion of patients, including prolonged, sustained partial responses. Furthermore, the addition of standard-of-care chemotherapy could further potentiate the anti-tumor effects of immunotherapy approaches by reducing the tumor burden, exposing antigens, and directly affecting the immunosuppressive TME compartment.
To explore the safety and synergy of the proposed combinatorial approach, participants with borderline resectable, locally advanced or mPC will receive nivolumab and ipilimumab administered in combination with gemcitabine and nab-paclitaxel followed by immune-chemoradiation.
Detailed description
Patients receive nivolumab and ipilimumab. Nivolumab 3 mg/kg will be given on Day 1 (± 3 days) of each 28-day treatment cycle. Ipilimumab 1 mg/kg will be given only on day 1 in cycle 1. Nivolumab will be administered as an IV infusion over 30 (± 5) minutes and then, after a 30 minutes rest period, ipilimumab will be administered as an IV infusion over 30 (± 5) minutes.
Pre-medication for chemotherapy (based on standard-of-care and local institutional standards) and chemotherapy will then be administered after a further 30 minutes rest period. The recommended dose of nab-paclitaxel is 100 mg/m2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8, and 15 of each 28-day cycle. Gemcitabine 800 mg/m2 will be adminestered over 30 to 40 minutes immediately after nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle.
At the beginning of cycle 3, patients also undergo concurrent MRI-guided adaptive SBRT (8 Gy x 3 fractions) delivered by ViewRay MR-Linear Accelerator.
Cycles repeats every 4 weeks for 4 courses (16 weeks) in the absence of disease progression, unacceptable toxicity, withdrawal of consent, or study closure.
Once 4 cycles of study treatment have been completed, subjects without disease progression or unacceptable toxicity may continue as per Investigator's Choice to either:
- Continuation of treatment with nivolumab, nab-paclitaxel and gemcitabine or surgery. Nivolumab can be continued until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or up to 12 cycles in total. Patients will receive chemotherapy until PD, unacceptable toxicity or withdrawal of consent, according to investigator's judgment
- If tumor response allows for surgical intervention, the subject will be eligible for that treatment as deemed appropriate by the investigators. Surgical intervention may not occur prior to completing the planned 4 cycles of nivolumab, nab-paclitaxel, gemcitabine and SBRT regardless the patient demonstrates a major response to therapy. Patients after PC resection will receive treatment until recurrence, unacceptable toxicity, withdrawal of consent, clear clinical deterioration, or for a maximum of 6 cycles, according to investigator's judgment Patients who discontinue without PD (stable disease (SD), partial response (PR), or complete response (CR)) will have both the safety follow-up period and survival follow-up period to occur simultaneously during the 2-year follow-up period. The duration of this follow-up is up to 2 years following the last dose of study treatment, although a longer follow-up period could be considered in selected cases if an efficacy signal is apparent. Patients will receive follow-up CT/MRI scans every 2 months (±14 days) until documented progression of disease, withdrawal of consent from active participation in the study, lost to follow-up, or for at least 2 years after start of treatment, whichever is earliest. Tumor evaluations will be assessed by the investigators and response to be determined according to response evaluation criteria in solid tumors (RECIST) v1.1 guidelines. Tumor assessment scans, for participants who have ongoing clinical benefit beyond the 2-year period from start of treatment, may continue to be collected as part of standard-of-care treatment. Subsequent therapies will also be recorded in this survival follow-up period.
All subjects who discontinue treatment for any reason will have a safety follow-up visit about 30, 60 and 100 days after treatment discontinuation and will be followed for OS and post-study anticancer therapies approximately every 90 days by phone or review of medical records until death, withdrawal of consent, or lost to follow-up.
To minimize the risks of adding or nivolumab + ipilimumab followed by nivolumab and chemo-radiation, safety will be monitored by a Bayesian stopping rule for the rate of treatment-related AEs leading to discontinuation greater than 30% (summarized baseline toxicity rate). For example, if 3 patients out of the first 6 or 4 out of the first 7 evaluable patients experience treatment-related AEs leading to discontinuation, accrual to the trial will be temporarily suspended and the principle investigator and study team will review the toxicity data and recommend either modification or termination of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Gemcitabine, Drug: Nab-paclitaxel, Drug: Nivolumab, Drug: Ipilimumab, Radiation: SBRTNivolumab 3 mg/kg will be given on day 1 (± 2 days) of each 28-day treatment cycle until the progression of disease, discontinuation due to toxicity, withdrawal of consent. Ipilimumab 1 mg/kg will be given once only on day 1 cycle 1. Nivolumab will be administered as an IV infusion over 30 (± 5) minutes and then, after a 30 minutes rest period, ipilimumab will be administered as an IV infusion over 30 (± 5) minutes. Pre-medication for chemotherapy (based on standard-of-care and local institutional standards) and chemotherapy will then be administered after a further 30 minutes rest period. The recommended dose of nab-paclitaxel is 100 mg/m2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8, and 15 of each 28-day cycle. Gemcitabine 800 mg/m2 will be administered over 30 to 40 minutes immediately after nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Signed informed consent
- Histological or cytological confirmation of locally advanced or metastatic pancreatic carcinoma prior to entering this study
- No prior chemotherapy regimens received for PC
- Age 18 years or older
- Life expectancy greater than 6 months
Key exclusion criteria (10 listed)
- Metastatic disease
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
- Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Participants with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
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 |
|---|---|---|
| Gemcitabine800 mg/m2 Day 1, 8, 15: Q4W IV Infusion | Drug | Experimental |
| Nab-paclitaxelAlso: Abraxane®100 mg/m2 Day 1, 8, 15: Q4W IV Infusion | Drug | Experimental |
| NivolumabAlso: Opdivo®3 mg/kg Day 1, Q4W IV Infusion | Drug | Experimental |
| IpilimumabAlso: Yervoy®1 mg/kg Day 1 Cycle 1 IV Infusion | Drug | Experimental |
| SBRTPatients will be planned and treated with SBRT on a MRidian MR guided Linac. Prescription dose shall be according to the following specifications: * Prescription dose shall be according to the following specifications: * A total dose of 24 Gy in 3 fractions (3 fractions/week) are prescribed as the mean dose to the PTV. * Pauses are accepted but the treatment should be delivered within 10 calendar days. * PTV should be covered by 95% isodose (PTV D99% >95%). | Radiation | Experimental |
Primary outcome
Incidence of treatment-related AEs, SAEs, AEs leading to discontinuation, death, and laboratory abnormalities
Time frame: 12 months
4 secondary outcomes
Median PFS using RECIST v1.1
Time frame: 12 months
Median OS
Time frame: 24 months
Objective Response Rate (ORR) by RECIST v1.1
Time frame: 12 months
Rate of downstaging to surgical resection
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Inna M Chen, MD principal investigator
Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gemcitabine, Nab-paclitaxel and Nivolumab in people with Borderline Resectable, Locally Advanced or Metastatic Pancreatic Cancer, run by Herlev Hospital at 1 site in Denmark.
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 18 inclusion and 10 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: finished, as of the sponsor's last update on 12 Mar 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 Denmark. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-related AEs, SAEs, AEs leading to discontinuation, death, and laboratory abnormalities (time frame: 12 months). 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 12 Mar 2025.