Trial Title:
A Study Evaluating Single-agent Inavolisib and Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers
NCT ID:
NCT06496568
Condition:
PIK3CA-Mutated Cancers
Conditions: Official terms:
Atezolizumab
Inavolisib
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Inavolisib
Description:
Participants will receive inavolisib, 9 milligram (mg), PO, QD on Days 1-21 of each
21-day cycle.
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Participants will receive atezolizumab, 1200 mg, as IV infusion Q3W on Day 1 of each
21-day cycle.
Arm group label:
Arm B
Summary:
The purpose of the study is to assess the safety and efficacy of inavolisib as a
single-agent and in combination with atezolizumab in participants with
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform
(PIK3CA)-mutated cancers, including previously treated head and neck squamous cell
carcinoma (HNSCC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed recurrent and/or metastatic HNSCC that has
been previously treated with systemic therapy in the recurrent and/or metastatic
setting
- Documented positive or negative human papillomavirus (HPV) status as determined
locally by p16 immunohistochemistry (IHC; preferred), in situ hybridization, and/or
by polymerase chain reaction-based assay
- Eligible participants must not be suitable for treatment with surgery and/or
radiation
- Confirmation of biomarker eligibility: Valid results from either central testing of
blood or local testing of blood or tumour tissue documenting PIK3CA-mutated tumour
status
- Consent to provide fresh (preferred) or archival tumour tissue specimen
- Negative hepatitis B surface antigen (HBsAg) and total hepatitis B core antibody
(HBcAb) test or positive total HBcAb test followed by a negative hepatitis B virus
(HBV) DNA at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV
antibody test followed by a negative HCV RNA test at screening
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of >=12 weeks
Exclusion Criteria:
- Prior treatment with any phosphatidylinositol 3-kinase (PI3K), protein kinase B
(AKT), or mammalian target of rapamycin (mTOR) inhibitor, or any agent whose
mechanism of action is to inhibit the PI3K/AKT/mTOR pathway
- Appropriate for treatment with surgery and/or radiation at the time of entry into
the study, as per national or local treatment guidelines
- Type II diabetes requiring ongoing systemic treatment at the time of study entry; or
any history of Type I diabetes
- Malabsorption syndrome or other condition that would interfere with enteral
absorption
- Known and untreated, or active central nervous system (CNS) metastases (progressing
or requiring anticonvulsants or corticosteroids for symptomatic control).
Participants with a history of treated CNS metastases are eligible provided they
meet specified criteria
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures twice per week or more frequently
- Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of
study treatment, or anticipation of the need for such a vaccine during study
treatment
- Any concurrent ocular or intraocular condition (e.g., cataract or diabetic
retinopathy) that, in the opinion of the investigator, would require medical or
surgical intervention during the study period to prevent or treat vision loss that
might result from that condition
- Active inflammatory (e.g., uveitis or vitritis) or infectious (e.g., conjunctivitis,
keratitis, scleritis, or endophthalmitis) conditions in either eye or history of
idiopathic or autoimmune-associated uveitis in either eye
- Requirement for daily supplemental oxygen
- Symptomatic active lung disease, including pneumonitis
- History of or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative
colitis) or any active bowel inflammation (including diverticulitis)
- Known Human Immunodeficiency Virus (HIV) infection
- Current severe, uncontrolled systemic disease (e.g., clinically significant
cardiovascular, pulmonary, metabolic, or infectious disease) or any other diseases,
active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational drug, that
may affect the interpretation of the results, or that renders the participant at
high risk from treatment complications
- Chemotherapy, radiotherapy, or any other anti-cancer therapy within 2 weeks before
enrolment
- Investigational drug(s) within 4 weeks before enrolment
- Unresolved toxicity from prior therapy, except for hot flashes, alopecia, and Grade
<=2 peripheral neuropathy
- History of other malignancy within 5 years prior to screening, with specified
exceptions
- History of or active clinically significant cardiovascular dysfunction
- Any serious medical condition or abnormality in clinical laboratory tests that, in
the investigator's judgment, precludes the participant's safe participation in and
completion of the study)
- Chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent
dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic
disease
- Allergy or hypersensitivity to components of the inavolisib formulation
- Treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors within 1 week or
five drug-elimination half-lives, whichever is longer, prior to initiation of study
treatment
- Major surgical procedure, or significant traumatic injury, within 28 days prior to
Day 1 of Cycle 1; or anticipation of the need for major surgery during study
treatment
- Minor surgical procedures <7 days prior to the first dose of study treatment
Exclusion criteria specific to arms utilizing atezolizumab:
- Prior serious immune-mediated toxicities resulting from treatment with any
checkpoint inhibitor including, but not limited to, atezolizumab, pembrolizumab, or
nivolumab
- Treatment with any checkpoint inhibitor within 5 half-lives of Day 1 of Cycle 1
- Uncontrolled or symptomatic hypercalcemia
- Active or history of autoimmune disease or immune deficiency, including, but not
limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid
antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré
syndrome, or multiple sclerosis, with specified exceptions
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
active pneumonitis on screening chest CT scan; a history of radiation pneumonitis in
the radiation field (fibrosis) is permitted
- Active tuberculosis
- Severe infection within 4 weeks prior to initiation of study treatment, including,
but not limited to, hospitalization for complications of infection, bacteraemia, or
severe pneumonia
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation
of study treatment; participants receiving prophylactic antibiotics may be eligible
for the study
- Prior allogeneic stem cell or solid organ transplantation
- Current treatment with anti-viral therapy for HBV
- Treatment with systemic immunostimulatory agents within 4 weeks or five
drug-elimination half-lives of the drug (whichever is longer)
- Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study treatment, or anticipation of the need for systemic
immunosuppressive medication during study treatment, with specified exceptions
- Poor peripheral venous access that would preclude repeated IV infusions
- History of severe allergic anaphylactic reactions to chimeric or humanized
antibodies or fusion proteins
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of
the atezolizumab formulation
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham Comprehensive Cancer Center
Address:
City:
Birmingham
Zip:
35249
Country:
United States
Status:
Withdrawn
Facility:
Name:
Moores Cancer Center at UC San Diego Health
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
California Cancer Associates for Research & Excellence, Inc.
Address:
City:
San Marcos
Zip:
92069
Country:
United States
Status:
Recruiting
Facility:
Name:
Vanderbilt-Ingram Cancer Ctr
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Facility:
Name:
BC Cancer Vancouver Centre
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Active, not recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Start date:
December 11, 2023
Completion date:
June 11, 2025
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06496568
