A Study Evaluating the Safety and Effectiveness of Therapies in Patients with Metastatic Colorectal Cancer

Overview

About this study

The purpose of this study for the Inavo + Cetux Arm:  To evaluate the effectiveness of Inavo + Cetux in PIK3CA-mutated colorectal cancer (CRC) with no detected RAS (KRAS, NRAS) or BRAFV600E mutations.

The purpose of this study for the Inavo + Bev Arm:  To evaluate the effectiveness Inavo + Bev in PIK3CA-mutated, RAS (KRAS, NRAS)-mutated CRC.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Signed next-generation sequencing (NGS) Biomarker Eligibility Informed Consent Form

- Age >= 18 years at time of signing Informed Consent Form

- Biomarker eligibility as determined at a College of American Pathologists/clinical
laboratory improvement amendments (CAP/CLIA)-certified or equivalently accredited
diagnostic laboratory using a validated test

- Eastern Cooperative Oncology Group (ECOG) Performance Status of <= 1

- Life expectancy >= 3 months, as determined by the investigator

- Histologically confirmed adenocarcinoma originating from the colon or rectum

- Metastatic disease

- Prior therapies for metastatic disease

- Ability to comply with the study protocol, in the investigators judgment

- Measurable disease (at least one target lesion) according to Response Evaluation
Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

- Availability of an archival tissue sample for exploratory biomarker research

- Adequate hematologic and organ function within 14 days prior to initiation of study
treatment

- For women of childbearing potential: Must have a negative serum pregnancy test result
within 14 days prior to initiation of study treatment and agreement to remain
abstinent or use contraceptive measures

- For men: agreement to remain abstinent or use contraceptive measures, and agreement to
refrain from donating sperm

Exclusion Criteria

- Current participation or enrollment in another interventional clinical trial

- Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is
shorter) prior to start of study treatment

- Treatment with investigational therapy within 28 days prior to initiation of study
treatment

- Pregnant or breastfeeding, or intending to become pregnant during the study

- History of or concurrent serious medical condition or abnormality in clinical
laboratory tests that, in the investigator's judgment, precludes the patient's safe
participation in and completion of the study or confounds the ability to interpret
data from the study

- Severe infection within 4 weeks prior to initiation of study treatment or any active
infection that, in the opinion of the investigator, could impact patient safety

- Incomplete recovery from any surgery prior to the start of study treatment that would
interfere with the determination of safety or efficacy of study treatment

- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures (once monthly or more frequently)

- Uncontrolled tumor-related pain

- Uncontrolled or symptomatic hypercalcemia

- Clinically significant and active liver disease

- Known HIV infection

- Symptomatic, untreated, or actively progressing CNS metastases

- History of leptomeningeal disease or carcinomatous meningitis

- History of malignancy other than CRC within 2 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death

- Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction,
physical examination finding, or clinical laboratory finding that contraindicates the
use of an investigational drug, may affect the interpretation of the results, or may
render the patient at high risk from treatment complications

- Requirement for treatment with any medicinal product that contraindicates the use of
any of the study treatments, may interfere with the planned treatment, affects patient
compliance, or puts the patient at higher risk for treatment-related complications

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/28/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jeremy Jones, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Joleen Hubbard, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Tanios Bekaii-Saab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions