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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed and documented advanced malignancies (locally advanced malignancies, non-curable by surgery or radiotherapy and metastatic disease). Disease must be measurable, including presence of at least one measurable lesion, as determined by RECIST v1.1.
HPV-associated head and neck squamous cell carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 31 months
Awards & highlights
Study Summary
This trial tests the safety & effectiveness of a drug to treat advanced cancers including lung, esophageal, renal and head/neck cancer.
Who is the study for?
Adults over 18 with advanced cancers like non-small cell lung, renal cell, esophageal squamous cell carcinoma, or HPV-related head and neck cancer. Participants must have measurable disease, be unresponsive to standard treatments or ineligible for them, and willing to undergo tumor biopsies. Exclusions include those with tuberculosis history, poor bone marrow function, serious infections including COVID-19, significant cardiac issues or a history of severe reactions to anti-PD-1 therapy.Check my eligibility
What is being tested?
The trial is testing the safety and effects of QEQ278 when given intravenously to patients with certain advanced solid tumors. It will assess how the body processes the drug (pharmacokinetics), its impact on the body (pharmacodynamics), tolerability at different doses and preliminary effectiveness in shrinking tumors.See study design
What are the potential side effects?
While specific side effects are not listed here for QEQ278 as it's under investigation, common side effects for similar cancer therapies may include fatigue, nausea, inflammation at injection sites and potential immune-related responses that could affect various organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, cannot be cured by surgery or radiation, and has at least one measurable lesion.
Select...
My cancer in the head or neck is linked to HPV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 31 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 31 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose intensity
Frequency of dose interruptions, reductions
Incidence and nature of Dose Limiting Toxicities (DLTs) during the DLT evaluation period for single agent QEQ278
+1 moreSecondary outcome measures
Area under the concentration time curve (AUC) infinity of QEQ278
Area under the concentration time curve (AUC) last of QEQ278
Disease control rate (DCR) per RECIST v1.1
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: Dose expansionExperimental Treatment1 Intervention
Dose expansion with QEQ278 single agent
Group II: Part 1: Dose escalationExperimental Treatment1 Intervention
Dose escalation with QEQ278 single agent
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,233 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with esophageal squamous cell carcinoma.I have never had severe lung inflammation.I do not have any serious uncontrolled infections.I am willing and able to have a tumor biopsy as per my hospital's rules.I have heart problems or risk factors for heart disease.I have an autoimmune disease but it's not severe or under control.I do not currently have any infections.My cancer in the head or neck is linked to HPV.My cancer is advanced, cannot be cured by surgery or radiation, and has at least one measurable lesion.My current treatments are not working, and I have no standard treatment options left.I am not on high-dose steroids or immunosuppressants, except for low-dose replacement therapy.I have a history of tuberculosis.My bone marrow is not working well.I have non-small cell lung cancer.I have been diagnosed with kidney cancer.You currently have Hepatitis B and/or Hepatitis C.You have a history of testing positive for HIV.I am 18 years old or older.I currently have a confirmed case of COVID-19.I stopped anti-PD-1 therapy because of its side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Dose escalation
- Group 2: Part 2: Dose expansion
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.
Has Part 2: Dose Expansion of this project been granted clearance by the U.S. Food and Drug Administration?
"Our team at Power has judged Part 2: Dose Expansion to have a score of 1 due to its Phase 1 status, which implies limited pre-existing evidence verifying the medication's safety and efficacy."
Answered by AI
Are medical professionals currently looking for participants in this trial?
"Affirmative, the data hosted on clinicaltrials.gov indicates that this medical research is currently seeking new participants. This trial was initially published on January 31st 2023 and has been updated most recently by January 11th of the same year. 125 people are expected to join at one location for this project."
Answered by AI
What are the fundamental aims of this experiment?
"Novartis Pharmaceuticals, the sponsor of this study, has outlined that over a 30-month period they will be assessing Frequency of dose interruptions and reductions as its primary outcome. Additionally, secondary objectives such as Elimination half-life (T1/2) of QEQ278, Total body clearance (CL)of QEQ278, and Volume of distribution (Vz)of QEQ278 will also be evaluated."
Answered by AI
What is the approximate number of participants enrolled in this clinical experiment?
"Yes, according to the latest information on clinicaltrials.gov, this experiment is presently recruiting patients for participation. The research commenced on January 31st 2023 and was recently updated on January 11th 2023; with a need of 125 individuals from one site."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
UCLA Medical Center Santa Monica Location
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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