Clinical trialPhase 1 / Phase 2Terminated
Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies
Phase 1/2 Open-label Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies
- Outcome
- Stopped earlyToxicity and Lack of Efficacy (Toxicity)
- Phase
- Phase 1 / Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 12 February 2020
- Expected end
- 1 July 2022
- Enrollment
- 27 participants
- Sites
- 2
- Primary outcomes
- Phase 1: Estimated Maximum Tolerated Dose (MTD) Hydroxychloroquine (HCQ); Phase 1: Estimated Maximum Tolerated Dose (MTD) Cobimetinib
- Sponsor
- Other
- Results posted
- 2024-12-18
- Last update
- 18 December 2024
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Brief summary public domain (ClinicalTrials.gov)
This research study is for patients with an advanced cancer that carries a mutation in a gene called KRAS. Genes are parts of our DNA which carry instructions for a cell (the smallest component of an body part). In many cancers, the KRAS gene contains errors (mutations) which allows the tumors to grow. The purpose of this study is to determine if combination treatment with atezolizumab, cobimetinib, and hydroxychloroquine is safe, and if it will decrease the size of the tumor and prolong life in patients whose tumors contain this mutation. Cobimetinib and atezolizumab are both approved by the FDA for use in other cancers, but not in some cancer types being studied in this trial. Hydroxychloroquine is FDA approved to treat malaria and other conditions, but has also not been approved for these cancer types. Preliminary results have shown that this combination of drugs is effective at killing cancer cells and shrinking tumors in several KRAS-mutated cancers in animals.
Detailed description public domain (ClinicalTrials.gov)
The overall objective of this study is to investigate the safety and preliminary efficacy of combination therapy with cobimetinib and hydroxychloroquine, with or without atezolizumab in patients with KRAS-mutated advanced malignancies. Given that the pre-clinical and clinical benefit from this combination is from within poorly differentiated endocrine carcinoma (PDAC) animal models and human subjects with PDAC and duodenal cancer, we will include at least 12 of the 18 evaluable subjects from PDAC and/or colorectal malignancies. The phase 2 portion of the study will be amended after preliminary safety and efficacy results from phase 1 and other ongoing clinical trials have been analyzed and a summary incorporated within the protocol as an amendment including a rationale of the cohorts to be tested.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase 1: Estimated Maximum Tolerated Dose (MTD) Hydroxychloroquine (HCQ) [28 days]. Number, mg. All Participants (n=14): 600.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Phase 1: Estimated Maximum Tolerated Dose (MTD) Cobimetinib [28 days]. Number, mg. All Participants (n=14): 40.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Phase 1: Number of Participants With Treatment-Emergent Adverse Events [Up to 20 weeks]. Count Of Participants, Participants. Phase I - Dose Level 1 (n=10): 9; Phase I - Dose Level 2 (n=4): 4.