Your session is about to expire
← Back to Search
Protein Kinase Inhibitor
Ipatasertib + Immunotherapy for Head and Neck Cancer
Phase 2
Recruiting
Led By Jacob S Thomas
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 (using the Cockcroft-Gault formula).
Patients must be able to provide an archival tissue specimen.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 year after the last patient is enrolled
Awards & highlights
Study Summary
This trial is comparing the effect of adding ipatasertib (a protein kinase B inhibitor) to standard immunotherapy (pembrolizumab) vs. pembrolizumab alone in treating patients with squamous cell cancer of the head and neck. Ipatasertib may stop the growth of tumor cells and may kill them. Pembrolizumab may help the body's immune system attack the cancer. Giving ipatasertib in combination with pembrolizumab may be more effective than pembrolizumab alone in improving some outcomes in patients with recurrent/metastatic squ
Who is the study for?
This trial is for adults with recurrent or metastatic squamous cell cancer of the head and neck, excluding nasopharynx cancers. Participants must not have had prior systemic therapy in the metastatic setting, should have proper organ function, no uncontrolled illnesses, and agree to use contraception. Those with certain viral infections must be under control. Pregnant or breastfeeding women are excluded.Check my eligibility
What is being tested?
The study compares adding Ipatasertib (an AKT inhibitor that may stop tumor growth) to Pembrolizumab (standard immunotherapy) versus using Pembrolizumab alone. The goal is to see if combining these drugs improves outcomes better than just the standard treatment.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions, fatigue, liver issues due to Ipatasertib's action on proteins within cells, and possibly increased cholesterol or blood sugar levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by GFR, is normal or above 60.
Select...
I can provide a sample of my previously collected tumor tissue.
Select...
My tumor has a PD-L1 score of 1 or higher.
Select...
I am 18 years old or older.
Select...
I am fully active or have some restrictions but can still care for myself.
Select...
My oropharyngeal cancer is tested for HPV status.
Select...
I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Select...
I have a tumor that can be measured with imaging or physical exam.
Select...
My cancer originates in the mouth, throat, or voice box, but not in the upper part of the throat behind the nose.
Select...
My hepatitis B virus is under control with treatment.
Select...
My head or neck cancer has returned or spread and cannot be cured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until disease progression, death, or date of last contact, whichever occurs first, assessed up to 1 year after the last patient is enrolled
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until disease progression, death, or date of last contact, whichever occurs first, assessed up to 1 year after the last patient is enrolled
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Changes in Akt, ERK, and MEK signaling
Changes in immune-cell population in peripheral blood
Changes in the tumor microenvironment by immunophenotyping
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (ipatasertib, pembrolizumab)Experimental Treatment5 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and ipatasertib PO QD on days 1-14 of each cycle. Cycles repeat every 21 days for a period of 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on study, undergo collection of blood samples on study and during follow up, and undergo CT scans throughout the trial.
Group II: Arm II (pembrolizumab)Active Control4 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for a period of 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy on study, undergo collection of blood samples on study and during follow up, and undergo CT scans throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Ipatasertib
2011
Completed Phase 3
~2320
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,925,829 Total Patients Enrolled
3 Trials studying Lip and Oral Cavity Cancer
376 Patients Enrolled for Lip and Oral Cavity Cancer
Jacob S ThomasPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have diabetes that requires insulin.I have received immunotherapy for cancer that returned or spread.I am HIV positive, on treatment, and my viral load is undetectable.I have a significant liver condition, such as hepatitis or cirrhosis.My kidney function, measured by GFR, is normal or above 60.My cholesterol and triglyceride levels are under control.I can provide a sample of my previously collected tumor tissue.My brain metastases are stable, and I haven't needed steroids for 14 days.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.Your kidney function is within the normal range.My tumor has a PD-L1 score of 1 or higher.I agree to use birth control or abstain from sex, and not donate sperm while on treatment and for 5 months after.I am 18 years old or older.I have recovered from previous cancer treatment side effects, except for mild neuropathy or hair loss.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I do not have conditions that affect my body's ability to absorb nutrients or prevent me from swallowing pills.I am fully active or have some restrictions but can still care for myself.I do not have any uncontrolled illnesses or a history of pneumonitis treated with steroids.You have had a severe allergic reaction to drugs similar to ipatasertib or pembrolizumab.Your AST and ALT levels in the blood should not be more than three times the normal range at the hospital where you are being treated.I can understand and am willing to sign the consent form, or I have someone who can do it for me.My oropharyngeal cancer is tested for HPV status.I have another cancer besides the one being studied, but it's either not progressing or doesn't need active treatment, except for certain skin cancers or cancers that have been treated with the goal of cure.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I haven't taken strong CYP3A affecting drugs recently.I am not pregnant or breastfeeding and won't plan to become pregnant or father a child during the study.I have a tumor that can be measured with imaging or physical exam.My brain scans show no worsening after treatment for brain metastases.You have enough platelets in your blood (at least 100,000 per microliter).Your total bilirubin levels are not higher than 1.5 times the upper limit of normal at the testing facility.I have another cancer type, but it won't affect this trial's treatment.I haven't received systemic therapy for cancer that has returned or spread.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.I do not have lung conditions like pneumonitis or cystic fibrosis.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.My cancer originates in the mouth, throat, or voice box, but not in the upper part of the throat behind the nose.You have enough infection-fighting white blood cells in your body.I have or have had inflammatory bowel disease or active bowel inflammation.My hepatitis B virus is under control with treatment.My head or neck cancer has returned or spread and cannot be cured.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (ipatasertib, pembrolizumab)
- Group 2: Arm II (pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Pembrolizumab a reliable treatment option with minimal risk of side-effects?
"There is evidence backing the safety of Pembrolizumab, which has led to its rating of 2 on our scale. Since this a Phase 2 trial, there have been no reports that support efficacy yet."
Answered by AI
Is this clinical trial still accepting participants?
"Per information on clinicaltrials.gov, this medical trial is still recruiting patients and was initially listed online on April 15th 2022 with a most recent update made November 2nd in the same year."
Answered by AI
What number of venues are currently hosting this research project?
"Patient enrolment is taking place at 5 different locations nationwide, including Los Angeles, Palo Alto and Duarte. For your convenience, it may be beneficial to choose the clinic located nearest you in order to reduce time spent travelling."
Answered by AI
What medical conditions can Pembrolizumab be employed to alleviate?
"Pembrolizumab has been found to be an effective treatment for malignant neoplasms, inoperable melanomas, and microsatellite instability high."
Answered by AI
Has research been conducted with regards to Pembrolizumab previously?
"The initial research on pembrolizumab began a decade ago at City of Hope. As of today, there have been 272 studies concluded and 991 active investigations taking place in numerous locations, many found close to Los Angeles."
Answered by AI
How many individuals are currently participating in this research study?
"Affirmative. According to clinicaltrials.gov, this research endeavour initiated on April 15th 2022 and was most recently updated November 2nd 2022 is currently in search of 48 individuals across 5 different sites."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger