Health TrialsbyHealthPanel

Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma

ConditionsPancreatic CancerPancreatic Cancer MetastaticPDACPDAC - Pancreatic Ductal AdenocarcinomaPancreatic Ductal Adenocarcinoma (PDAC)Pancreatic Adenocarcinoma MetastaticPancreatic AdenocarcinomaPancreatic Adenosquamous Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRevolution Medicines, Inc.

About this trial

The purpose of this study is to evaluate the efficacy of combination therapy with two investigational RAS(ON) inhibitors (daraxonrasib and zoldonrasib) compared to chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years old and has provided informed consent.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Histologically or cytologically confirmed pancreatic adenocarcinoma, including adenosquamous carcinoma, not previously treated in the locally advanced unresectable or metastatic setting.

No prior treatment in the locally advanced unresectable or metastatic setting

Disqualifiers

Mutation status with known driver mutations for which there are approved targeted therapies.

Acinar cell carcinoma, pancreatic neuroendocrine tumors, tumors involving islet cells or islet cell neoplasms, and other non-adenocarcinoma pancreatic malignancies.

Tumors determined to originate from non-pancreatic primary sites.

Prior treatment with MAPK-pathway targeted therapy or administration of RAS-targeted vaccine in the metastatic setting.

Trial design

Design model

Parallel

Treatments tested in this trial

  • daraxonrasib

    Drug

    oral tablets

  • gemcitabine

    Drug

    intravenous (IV) infusion

  • nab-paclitaxel

    Drug

    IV infusion

  • zoldonrasib

    Drug

    oral tablets

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Arm A: daraxonrasib + zoldonrasibExperimental treatment 2 interventions
Group B: Arm B: gemcitabine and nab-paclitaxelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.

Time frame
Up to approximately 4 years
2

Overall survival (OS)

OS is defined as the time from randomization until death from any cause.

Time frame
Up to approximately 4 years

Secondary outcomes

1

PFS by blinded independent central review (BICR)

PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by BICR

Time frame
Up to approximately 4 years
2

Objective response rate (ORR)

Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator.

Time frame
Up to approximately 4 years
3

Duration of response (DOR)

DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the investigator.

Time frame
Up to approximately 4 years
4

Incidence of adverse events (AEs)

Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5

Time frame
Up to approximately 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Revolution Medicines, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now