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Monoclonal Antibodies
CPI-006 Combinations for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Corvus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment to end of treatment, up to 36 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug, CPI-006, alone and in combination with other drugs, to see if it is safe and effective in treating advanced cancer.
Who is the study for?
This trial is for adults with certain advanced cancers who have had limited prior treatments, can perform daily activities without significant assistance (ECOG 0-1), and have at least one measurable tumor. It's not for those with untreated brain metastases, severe reactions to monoclonal antibodies, recent investigational drug use, or specific immunotherapy-related side effects.Check my eligibility
What is being tested?
The study tests CPI-006 alone and in combination with ciforadenant or pembrolizumab in patients with select advanced cancers. It's a Phase 1/1b trial aiming to find the right dose and see how safe and effective these combinations are against various cancer types.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to immune therapies such as inflammation of organs, infusion-related symptoms, allergic reactions similar to past monoclonal antibody treatments, fatigue, skin issues, and possibly pneumonitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment to end of treatment, up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment to end of treatment, up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Identify the MDL(maximum dose level) of single agent CPI-006
Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.
Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.
Secondary outcome measures
Area under the curve (AUC) of CPI-006
Serum
Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Cohort1bExperimental Treatment1 Intervention
CPI-006 + ciforadenant
Group II: Cohort 2cExperimental Treatment1 Intervention
CPI-006 + pembrolizumab
Group III: Cohort 2bExperimental Treatment1 Intervention
CPI-006 + ciforadenant
Group IV: Cohort 2aExperimental Treatment1 Intervention
CPI-006
Group V: Cohort 1cExperimental Treatment1 Intervention
CPI-006 + pembrolizumab
Group VI: Cohort 1aExperimental Treatment1 Intervention
CPI-006
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPI-006 + pembrolizumab
2018
Completed Phase 1
~120
CPI-006
2018
Completed Phase 1
~150
CPI-006 + ciforadenant
2018
Completed Phase 1
~120
Find a Location
Who is running the clinical trial?
Corvus Pharmaceuticals, Inc.Lead Sponsor
7 Previous Clinical Trials
824 Total Patients Enrolled
S Mahabhashyam, MDStudy ChairCorvus Pharmaceuticals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are able to perform daily activities without assistance or with minimal help.If you're in the first group, you've tried 1 to 5 treatments before. If you're in the second group, you've had your disease get worse, didn't respond to, or couldn't tolerate 1 to 3 treatments before.You have at least one detectable tumor that can be measured using specific criteria.You have untreated or worsening brain tumors that are causing symptoms.You have had a serious allergic reaction to monoclonal antibodies in the past.You should be in good enough health to perform daily activities without any problems.You have had a lung inflammation that wasn't caused by an infection and needed treatment with steroids, or you currently have lung inflammation.You have taken certain medications for cancer treatment in the past, and any side effects from those medications need to be completely resolved before you can join the study.You have a type of cancer that cannot be cured.For the first part, you have tried at least one but not more than five treatments for your advanced or recurring disease. For the second part, you have either not responded well to or could not tolerate one to three previous treatments.You are willing to have a sample of your tumor taken for testing.You have a type of cancer that cannot be cured, such as lung, kidney, breast, colorectal, bladder, cervical, uterine, or prostate cancer.You have at least one noticeable and measurable tumor according to specific guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort1b
- Group 2: Cohort 1c
- Group 3: Cohort 2a
- Group 4: Cohort 2b
- Group 5: Cohort 2c
- Group 6: Cohort 1a
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.
Non-Hodgkin's Lymphoma Patient Testimony for trial: Trial Name: NCT03454451 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many sites are hosting this investigation?
"Across the United States, 26 medical centres are currently enrolling patients. These locations include Yale School of Medicine in New Haven, Virginia Cancer Specialists PC in Fairfax and Northwestern University Chicago; as well as 23 additional sites."
Answered by AI
What indications is CPI-006 primarily indicated for?
"CPI-006 is generally used to address malignant neoplasms, but it has also been known to help those with unresectable melanoma, microsatellite instability high and chemotherapy-resistant conditions."
Answered by AI
What is the total sample size of this medical investigation?
"Unfortunately, no further participants are currently being accepted for this trial. Its first posting was on April 25th 2018 and it has most recently been updated on August 1st 2022. However, there are numerous other studies open to enrollment; 3805 trials studying sarcoma patients and 964 clinical trials investigating CPI-006 seek enrollees at present."
Answered by AI
What possible risks do participants face when using CPI-006?
"Our assessment of CPI-006's safety is a 1, as this trial has only just begun and little evidence exists of the treatment's efficacy or safety."
Answered by AI
Has CPI-006 been tested in other scientific experiments?
"At present, 964 studies are in progress to investigate CPI-006 with 122 reaching the final stage of medical trials. Most investigations for this drug are happening in Houston, Texas however 35810 sites around the world host research on CPI-006."
Answered by AI
Are there any opportunities for patients to partake in this clinical trial?
"According to clinicaltrials.gov, this trial is not currently enrolling patients. It was initially posted on April 25th 2018 and has been updated most recently on August 1st 2022. However, there are over 4700 other trials recruiting participants at the present moment in time."
Answered by AI
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Iyhis trail is truly relu important to me as to find out and study if I do have any symptoms of any chronic illness that I myself should be aware as a male of 54 year of age so I start to seek treatment of any to cure my illness.
PatientReceived no prior treatments
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