Home › Trials › NCT06115499

Optimizing chemotherapy for metastatic pancreatic cancer with specific genetic mutations

Phase II/III Second-Line NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma (PLATINUM)

Phase2; Phase3 Interventional Alliance for Clinical Trials in Oncology · NCT06115499

This study is testing whether a new three-drug chemotherapy combination can help people with metastatic pancreatic cancer and specific genetic mutations live longer and feel better compared to a two-drug option.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorAlliance for Clinical Trials in Oncology Academic / other
Drugs / interventionschemotherapy
Locations309 sites (Anchorage, Alaska and 308 other locations)
Trial IDNCT06115499 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of a three-drug chemotherapy regimen consisting of nab-paclitaxel, gemcitabine, and cisplatin compared to a two-drug regimen of nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer who have BRCA1, BRCA2, or PALB2 mutations. The study aims to determine overall response rates and overall survival times in patients whose disease has progressed after initial treatment with FOLFIRINOX. Participants will be randomized into two treatment arms to assess the efficacy and safety of the different chemotherapy combinations.

Who should consider this trial

Good fit: Ideal candidates include patients with metastatic pancreatic cancer who have a confirmed BRCA1, BRCA2, or PALB2 mutation and have experienced disease progression after first-line chemotherapy.

Not a fit: Patients without BRCA1, BRCA2, or PALB2 mutations or those who have not progressed after first-line treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with specific genetic mutations associated with metastatic pancreatic cancer.

How similar studies have performed: Other studies have shown promising results with similar chemotherapy approaches in treating pancreatic cancer, but this specific combination is being evaluated for the first time in this genetic context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Metastatic pancreatic adenocarcinoma. Adenosquamous carcinoma, squamous carcinoma, acinar cell carcinoma, and carcinoma not otherwise specified are also acceptable
* BRCA1/2 or PALB2 mutation (somatic or germline) identified on any Clinical Laboratory Improvement Amendments (CLIA)-certified gene panel. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org. (Submission of mutation report will be required)
* Measurable disease
* Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment
* Clinical or radiographic progression on first-line FOLFIRINOX (or nanoliposomal irinotecan, fluorouracil, leucovorin, and oxaliplatin \[NALIRIFOX\]) for metastatic disease

  * Patients whose front-line chemotherapy was required to be simplified due to toxicity associated with any of the constituent components of FOLFIRINOX/NALIRIFOX (e.g. simplified to leucovorin calcium, fluorouracil, and oxaliplatin \[FOLFOX\], leucovorin calcium, fluorouracil, and irinotecan \[FOLFIRI\], fluorouracil \[5-FU\] \[including capecitabine\]) will be eligible
  * Patients with progressive disease while on maintenance PARP inhibitor treatment after FOLFIRINOX (or NALIRIFOX), irrespective of how long ago they received FOLFIRINOX/NALIRIFOX, will also be eligible
  * Patients who develop metastatic disease during or within 6 months after completing FOLFIRINOX/NALIRIFOX in either the locally advanced or adjuvant/neoadjuvant settings will be eligible
* Patients may not have received prior cisplatin for their pancreatic cancer in any setting

  \* Note: Patients may have previously received gemcitabine +/- nab-paclitaxel for resectable (neoadjuvant/adjuvant) or locally advanced disease if (1) treatment was completed \> 1 year ago and (2) in the opinion of the treating provider, re-treatment with gemcitabine/nab-paclitaxel is appropriate
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky performance status \>= 60)
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 8.0 g/dL
* Creatinine =\< 1.8 x institutional upper limit of normal (ULN) or calculated creatinine clearance (Calc. CrCl) \> 40 mL/min
* Total bilirubin =\< 2.0 x institutional ULN

  \* Any elevated bilirubin should be asymptomatic at enrollment (except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin =\< 3 x ULN or direct bilirubin =\< 1.5 x ULN)
* Aspartate transaminase (AST)/alanine transaminase (ALT) =\< 3 x institutional ULN

  \* AST/ALT of =\< 5 x ULN if liver metastases are present
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

  \* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
* Patients with \> grade 2 peripheral sensory neuropathy are not eligible
* Patients 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
* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 8-weeks.

  \* Patients with known, new or progressive brain metastases (active brain metastases) or leptomeningeal disease are ineligible
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load anytime within 6 months prior to registration are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

  \* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Concomitant chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment

Exclusion Criteria:

* N/A

Where this trial is running

Anchorage, Alaska and 308 other locations

+259 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreatic Acinar Cell CarcinomaPancreatic AdenocarcinomaPancreatic Adenosquamous CarcinomaPancreatic CarcinomaPancreatic Ductal AdenocarcinomaPancreatic Squamous Cell CarcinomaStage IV Pancreatic Cancer AJCC v8
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.