SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT02091141

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

My Pathway: An Open-Label Phase IIa Study Evaluating Trastuzumab/Pertuzumab, Erlotinib, Vemurafenib/Cobimetinib, Vismodegib, Alectinib, and Atezolizumab in Patients Who Have Advanced Solid Tumors With Mutations or Gene Expression Abnormalities Predictive of Response to One of These Agents

This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.

NCT02091141 Neoplasms Solid Tumors Biliary Cancer Salivary Cancer Bladder Cancer

8 Interventions

Name: Trastuzumab

Description: Trastuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Type: Drug
Group Labels: 1

Trastuzumab Plus Pertuzumab

Name: Pertuzumab

Description: Pertuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Type: Drug
Group Labels: 1

Trastuzumab Plus Pertuzumab

Name: Erlotinib

Description: Erlotinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Type: Drug
Group Labels: 1

Erlotinib

Name: Vemurafenib

Description: Vemurafenib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Type: Drug
Group Labels: 1

Vemurafenib Plus Cobimetinib

Name: Cobimetinib

Description: Cobimetinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Type: Drug
Group Labels: 1

Vemurafenib Plus Cobimetinib

Name: Vismodegib

Description: Vismodegib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Type: Drug
Group Labels: 1

Vismodegib

Name: Alectinib

Description: Alectinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Type: Drug
Group Labels: 1

Alectinib

Name: Atezolizumab

Description: Atezolizumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
Type: Drug
Group Labels: 1

Atezolizumab


Primary Outcomes

Description: Tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for all arms.

Measure: Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator

Time: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (up to approximately 5 years)

Description: Tumor response will be assessed using RECIST version 1.1.

Measure: Percentage of Atezolizumab-Treated Participants With Tissue Tumor Mutational Burden (tTMB) ≥16 Mutations/Mb With Overall Response, as Assessed by the Independent Review Committee (IRC)

Time: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (up to approximately 5 years)

Secondary Outcomes

Description: Tumor response will be assessed using RECIST version 1.1 for all arms.

Measure: Percentage of Participants With Disease Control

Time: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (up to approximately 5 years)

Description: Tumor response will be assessed using RECIST version 1.1 for all arms.

Measure: Progression-Free Survival (PFS)

Time: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (up to approximately 5 years)

Measure: Percentage of Participants who are Alive at Year 1

Time: 1 year

Description: Tumor response will be assessed using RECIST version 1.1 for all arms.

Measure: Duration of Response

Time: From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first (up to approximately 5 years)

Description: Tumor response will be assessed using RECIST version 1.1.

Measure: Percentage of Atezolizumab-Treated Participants with tTMB ≥10 Mutations/Mb and <16 Mutations/Mb With Overall Response, as Assessed by the Investigator

Time: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (up to approximately 5 years)

Description: Tumor response will be assessed using RECIST version 1.1.

Measure: Percentage of Atezolizumab-Treated Participants with Blood Tumor Mutational Burden (bTMB) ≥16 Mutations With Overall Response, as Assessed by the IRC

Time: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (up to approximately 5 years)

Measure: Percentage of Participants With Adverse Events

Time: From first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 5 years)

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

The tissue sample must be submitted within 4 weeks after enrollment General Exclusion Criteria: - Participants with hematologic malignancies - Concurrent administration of any other anti-cancer therapy (except male participants with prostate cancer receiving androgen blockade): Bisphosphonates and denosumab are allowed; Most recent anti-cancer therapy ≤28 days and have not recovered from the side effects, excluding alopecia; Radiation therapy within ≤14 days - Active or untreated brain metastases - History of carcinomatous meningitis - Uncontrolled concurrent malignancy (early stage is allowed if not requiring active therapy or intervention) - Pregnant or breastfeeding women, or intending to become pregnant during the study - Any significant cardiovascular events within 6 months prior to study entry - Pulmonary embolism within 30 days prior to study entry - History or presence of clinically significant ventricular or atrial dysrhythmia >Grade 2 per NCI CTCAE v4.0 - Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results - Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol Study-Drug Specific Exclusion Criteria: Trastuzumab plus Pertuzumab - Previous treatment with any HER2-targeted therapy Erlotinib - Non-small cell lung cancer (NSCLC) or pancreatic cancer identified by exon 19 deletions or exon 21 L858R substitution mutations - EGFR amplifications in the absence of EGFR-activating mutations - Cancers with exon 20 mutations - Previous treatment with erlotinib or any other EGFR inhibitor - Inability to swallow pills - Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of erlotinib Vemurafenib plus Cobimetinib - Malignant melanoma, papillary thyroid cancer, colorectal cancer, or hematologic malignancy including multiple myeloma - LVEF below institutional lower level of normal (LLN) or below 50%, whichever is lower - History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration - Presence of any of the following conditions, which are risk factors for RVO: Uncontrolled glaucoma with intraocular pressure >21 millimetres of mercury (mm Hg); Serum cholesterol ≥Grade 2; Hypertriglyceridemia ≥Grade 2; Hyperglycemia (fasting) ≥Grade 2; Grade ≥2 uncontrolled hypertension (participants with a history of hypertension controlled with anti-hypertensive medication to Grade L858R ---



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