NCT06115499|Active Not RecruitingPhase 2

The PLATINUM Trial: Optimizing Chemotherapy for the Second-Line Treatment of Metastatic BRCA1/2 or PALB2-Associated Metastatic Pancreatic Cancer

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

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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2 other identifiers

A022106NCI-2023-06547

Study Type

interventional

Target

Locations

1 country

Sites

345

Timeline

RegisteredNov 2023

StartedAug 2024

CompletionDec 2029

Brief Summary

This phase II/III trial compares the effect of the 3-drug chemotherapy combination of nab-paclitaxel, gemcitabine, plus cisplatin versus the 2-drug chemotherapy combination of nab-paclitaxel plus gemcitabine for the treatment of patients with pancreatic cancer that has spread to other places in the body (metastatic) and a known genetic mutation in the BRCA1, BRCA2, or PALB2 gene.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

44mo left

Started Aug 2024

Longer than P75 for phase_2

Geographic Reach

1 country

345 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.3 years study duration

Study Progress33%

Aug 2024Dec 2029

First Submitted

Initial submission to the registry

October 30, 2023

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed

9 months until next milestone

Study Start

First participant enrolled

August 13, 2024

Completed

4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2029

Expected

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2029

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

4.4 years

First QC Date

October 30, 2023

Last Update Submit

January 6, 2026

Conditions

Pancreatic Acinar Cell Carcinoma Pancreatic Carcinoma Pancreatic Squamous Cell Carcinoma Pancreatic Adenocarcinoma Pancreatic Adenosquamous Carcinoma Pancreatic Ductal Adenocarcinoma Stage IV Pancreatic Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

Overall response rate (ORR) (Phase II)
Will be assessed by the proportion of patients who achieve complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) during the protocol treatment. Fisher's exact test will be conducted based on the first 32 patients in each arm who meet PP population criteria.
Up to 12 months
Overall Survival (OS) (Phase III)
Will be conducted on modified intention-to-treat population. Stratified Cox model will be constructed to compare OS in the experimental arm to OS in the control arm.
From the date of randomization to the date of death due to all causes, assessed up to 5 years

Secondary Outcomes (2)

Progression-free survival
From the date of randomization to the date of first documented disease progression or death due to all causes, whichever occurs first, assessed up to 5 years
Incidence of adverse events
Up to 30 days after the last dose of study treatment

Study Arms (2)

Arm I (nab-paclitaxel, gemcitabine, cisplatin)

EXPERIMENTAL

Patients receive nab-paclitaxel IV over 30-40 minutes, gemcitabine IV over 30-40 minutes, and cisplatin IV over 30-60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.

Drug: Nab paclitaxelDrug: GemcitabineDrug: CisplatinProcedure: Magnetic Resonance ImagingProcedure: Computed TomographyProcedure: Biospecimen Collection

Arm II (nab-paclitaxel, gemcitabine)

ACTIVE COMPARATOR

Patients receive nab-paclitaxel IV over 30-40 minutes and gemcitabine IV over 30-40 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT throughout the trial. Patients may optionally undergo blood sample collection at baseline and on study.

Drug: Nab paclitaxelDrug: GemcitabineProcedure: Magnetic Resonance ImagingProcedure: Computed TomographyProcedure: Biospecimen Collection

Interventions

Nab paclitaxelDRUG

Given IV

Also known as: ABI-007, Abraxane, Albumin-bound Paclitaxel, Protein-bound Paclitaxel

Arm I (nab-paclitaxel, gemcitabine, cisplatin)Arm II (nab-paclitaxel, gemcitabine)

CisplatinDRUG

Given IV

Arm I (nab-paclitaxel, gemcitabine, cisplatin)

GemcitabineDRUG

Given IV

Arm I (nab-paclitaxel, gemcitabine, cisplatin)Arm II (nab-paclitaxel, gemcitabine)

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: MRI

Arm I (nab-paclitaxel, gemcitabine, cisplatin)Arm II (nab-paclitaxel, gemcitabine)

Computed TomographyPROCEDURE

Undergo CT

Also known as: CAT Scan, CT Scan

Arm I (nab-paclitaxel, gemcitabine, cisplatin)Arm II (nab-paclitaxel, gemcitabine)

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Arm I (nab-paclitaxel, gemcitabine, cisplatin)Arm II (nab-paclitaxel, gemcitabine)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+16 more criteria

You may not qualify if:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (345)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC