Clinical trialPhase 2Completed

Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer

A Phase II Trial of Vemurafenib in Combination With Sorafenib to Treat Patients With Advanced KRAS Mutated Pancreatic Cancer: Targeting RAF Dimers to Suppress Oncogenic RAS Signaling (The Dr. Nate Nieto Study)

NCT05068752 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Outcome unknown
Phase: Phase 2
Status: Completed
Study type: Interventional
Start: 28 October 2021
Expected end: 13 December 2024
Enrollment: 10 participants
Sites: 1
Primary outcomes: Disease Control Rate (DCR)
Sponsor: Other
Results posted: 2026-03-30
Last update: 30 March 2026

These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.

Ask this document

Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.

Try

Source text

Brief summary public domain (ClinicalTrials.gov)

The purpose of this research is to determine the benefit of two oral chemotherapy drugs, Vemurafenib and Sorafenib, in individuals with KRAS mutated pancreatic cancer who have progressed on standard chemotherapy.

Intervention public domain (ClinicalTrials.gov)

Drug: Vemurafenib. Vemurafenib 480 mg PO BID daily given with Sorafenib 200 mg PO BID

Intervention public domain (ClinicalTrials.gov)

Drug: Sorafenib. Sorafenib 200 mg PO BID and Vemurafenib 480 mg PO BID daily

Arm public domain (ClinicalTrials.gov)

Vemurafenib in Combination with Sorafenib (experimental):

Primary outcome public domain (ClinicalTrials.gov)

Disease Control Rate (DCR). Disease control rate (DCR) is defined as the combination of patients with complete response + partial response + stable disease at 16 weeks, divided by the total number of patients. Response is defined using RECIST v1.1 imaging criteria. Time frame: Initiation of study treatment until 16 weeks..

Secondary outcome public domain (ClinicalTrials.gov)

Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib. Time frame: Initiation of study treatment up to 30 days post treatment, an average of 90 days.

Secondary outcome public domain (ClinicalTrials.gov)

Progression-free Survival (PFS). Time frame: Initiation of study treatment up to study completion, up to 2 years..

Secondary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS). Time frame: Initiation of study treatment up to study completion, up to 2 years..

Secondary outcome public domain (ClinicalTrials.gov)

Percent Change in Plasma Levels of Phospho-ERK From Baseline. Time frame: Initiation of study treatment to end of study treatment, up to 90 days..

Secondary outcome public domain (ClinicalTrials.gov)

Percent Change in Plasma Levels of Phospho-AKT From Baseline. Time frame: Initiation of study treatment to end of study treatment, up to 90 days..

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: 1. Be able to understand and be willing to sign the written informed consent for the trial. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure. 2. Be ≥ 18 years of age on day of signing informed consent. 3. Histologically confirmed cancer of the pancreas (KRAS mutated) with metastases and progression on at least ≥ 2 prior treatment regimens for their disease. 4. Known mutation status of KRAS and BRAF kinases. For those patients in which this has not previously been determined, the patient must have an archival tumor specimen (primary or metastatic site) available to submit to confirm KRAS and BRAF status. 5. Have a performance status of 0 or 1 on the ECOG performance scale. 6. Demonstrate adequate organ function 7. Female participants of childbearing potential must have a negative serum pregnancy test performed within 24 hours prior to receiving first dose of trial medication. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. 8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of trial treatment. 9. Male participants must agree to use contraception during the treatment period and for at least 30 days after the last dose of trial treatment and refrain from donating sperm during this period. 10. Patient must have QTC of ≤500ms. 11. Subject must be able to swallow and retain oral medication 12. Measurable disease per RECIST 1.1 Exclusion Criteria: 1. Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 2 weeks of the first dose of this trials' treatment. 2. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1/Day 1 or who has not recovered (i.e. NCI-CTC AE Version 5.0 ≤ Grade 1 at the time of signing informed consent) from adverse events due to a previously administered agent(s). 3. Previous BRAF inhibitor use such as vemurafenib, GSK2118436 or sorafenib. 4. If patient received major surgery, and has not yet recovered …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 10 participants (actual).

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Disease Control Rate (DCR) [Initiation of study treatment until 16 weeks.]. Number, DCR, % of participants with CR/PR/SD. Vemurafenib in Combination With Sorafenib (n=9): 0.