A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy

Mandana Kamgar, MD

Status: Enrolling

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Drug: combination therapy with MEKi.; Other: combination therapy with no MEKi; Drug: combination therapy with MEKi-HCQ; Drug: combination therapy with MEKi-EGFRi

Study type: Observational

Funder types: Other

Identifiers

NCT05630989

PRO00045718

Details and patient eligibility

About

This is an observational precision oncology study designed to collect and analyze data that allows us to characterize the safety and efficacy of several different mitogen-activated protein kinase kinase inhibitor (MEKi) -based treatment strategies and the feasibility of administering MEKi combination therapies to patients with KRAS G12R mutated advanced pancreatic ductal adenocarcinoma (PDAC).

Full description

Patient medical records, obtained both retrospectively and prospectively, will be examined for results of molecular profiling obtained through standard of care testing to help understand how well KRAS G12R pancreatic patients respond to MEKi-based combination matched therapy. Patient outcome parameters including but not limited to tumor response, patient survival, and toxicity will be analyzed. Moreover, metrics will be collected to ascertain whether a future clinical trial involving a MEKi-based combination therapy is feasible to carry out.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years.
2. Diagnosis of advanced pancreatic ductal adenocarcinoma as determined by the treating physician or tumor board.
3. Tumor must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician.
4. Ability to understand a written informed consent document and the willingness to sign it.

Exclusion criteria

1. Age <18 years.
2. Primary cancer diagnosis other than advanced pancreatic ductal adenocarcinoma
3. Tumor does not have a KRAS G12R mutation.

Trial design

80 participants in 4 patient groups

Therapy with no MEKi

Description:

Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive therapy with no MEKi.

Treatment:

Other: combination therapy with no MEKi

Therapy with MEKi- Hydroxychloroquine (HCQ)

Description:

Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive therapy with MEKi and HCQ.

Treatment:

Drug: combination therapy with MEKi-HCQ

Therapy with MEKi- Epidermal growth factor receptor inhibitor (EGFRi)

Description:

Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive combination therapy with MEKi and EGFRi.

Treatment:

Drug: combination therapy with MEKi-EGFRi

Therapy with MEKi-Other

Description:

Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician. Subjects will receive combination therapy with MEKi and a specified drug combination.

Treatment:

Drug: combination therapy with MEKi.