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Small Molecule Inhibitor
Navtemadlin +/− Immunotherapy for Skin Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Kartos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Cohort 1, 3 and 4 patients must have failed treatment with at least one PD-1 inhibitor or PD-L1 inhibitor for metastatic MCC
ECOG performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after last subject enrolled.
Awards & highlights
Study Summary
This trial is testing a new drug to treat Merkel cell carcinoma, a type of skin cancer. The drug works by targeting a protein called MDM2. Previous treatments haven't worked for patients with this cancer, so this trial is testing to see if this new drug is effective.
Who is the study for?
This trial is for patients with Merkel Cell Carcinoma who have tried at least one anti-PD-1 or anti-PD-L1 therapy, except for one group that hasn't had these treatments. Participants must be in good physical condition (ECOG 0-1), have measurable cancer lesions, and proper organ function. Those with major organ transplants, certain autoimmune diseases, previous MDM2 antagonist therapies, untreated brain metastases, or significant heart rhythm issues cannot join.Check my eligibility
What is being tested?
The study tests KRT-232 alone or combined with Avelumab in different groups of MCC patients based on their prior treatments. KRT-232 targets a protein called MDM2 to fight cancer cells. The goal is to see if this new approach works better for those who haven't responded well to existing immunotherapies.See study design
What are the potential side effects?
Potential side effects include typical reactions from immune-based cancer therapies such as fatigue, skin reactions, inflammation-related symptoms affecting various organs and possible blood abnormalities due to the novel mechanism of action targeting MDM2.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried at least one PD-1 or PD-L1 inhibitor for my metastatic MCC without success.
Select...
I can carry out all my usual activities without help.
Select...
My MCC is p53WT positive according to a certified test.
Select...
I have had at least one chemotherapy treatment before.
Select...
I have not had chemotherapy before.
Select...
My MCC is p53WT positive according to a lab test.
Select...
My Merkel cell carcinoma is confirmed and can be measured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year after last subject enrolled.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after last subject enrolled.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 1 Part 1: To determine the KRT-232 RP2D.
Cohort 1 Part 2: To determine the objective response rate (ORR) in subjects with p53WT MCC who have failed anti-PD-1 or anti-PDL-1 immunotherapy
Cohort 2 Part 1: To determine the KRT-232 RP2D in combination with avelumab
+3 moreSecondary outcome measures
To determine Progression-free survival (PFS)
To determine clinical benefit rate (CBR)
To determine overall survival (OS)
+2 moreSide effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Investigations
6%
Metabolism and nutrition disorders
6%
General disorders and administration site conditions
6%
Gastrointestinal disorders
6%
Nervous system disorders
6%
Cardiac disorders
6%
Infections and infestations
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
Trial Design
11Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
KRT-232 will be administered orally, once daily (QD) per Cohort 1 RP2D dose and schedule.
Group II: Cohort 3Experimental Treatment1 Intervention
KRT-232 will be administered orally, once daily (QD) per Cohort 1 RP2D dose and schedule.
Group III: Cohort 2, Arm 2 KRT-232 in combination with avelumabExperimental Treatment2 Interventions
KRT-232 will be administered orally, once daily (QD) on Days 1-7, in combination with avelumab 800 mg IV on Day 1 and 15 in a 28-day cycle.
Group IV: Cohort 2, Arm 1 KRT-232 in combination with avelumabExperimental Treatment2 Interventions
KRT-232 will be administered orally, once daily (QD) on Days 1-5, in combination with avelumab 800 mg IV on Day 1 and 15 in a 28-day cycle.
Group V: Cohort 2 ExpansionExperimental Treatment2 Interventions
KRT-232 will be administered orally, once daily (QD) per RP2D dose and schedule, in combination with avelumab 800 mg IV on Day 1 and 15 in a 28-day cycle.
Group VI: Cohort 1, Arm 5Experimental Treatment1 Intervention
KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle.
Group VII: Cohort 1, Arm 3Experimental Treatment1 Intervention
KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 21-day cycle.
Group VIII: Cohort 1, Arm 2bExperimental Treatment1 Intervention
KRT-232 will be administered orally, once daily (QD) on Days 1-5 in a 28-day cycle.
Group IX: Cohort 1, Arm 1bExperimental Treatment1 Intervention
KRT-232 will be administered orally, once daily (QD) on Days 1-5 in a 23-day cycle.
Group X: Cohort 1, Arm 1Experimental Treatment1 Intervention
KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 21-day cycle.
Group XI: Cohort 1 ExpansionExperimental Treatment1 Intervention
KRT-232 will be administered orally, once daily (QD) per Cohort 1 RP2D dose and schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Find a Location
Who is running the clinical trial?
Kartos Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
1,335 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have autoimmune diseases, need for immunosuppressants, had a stem cell transplant, or active hepatitis B or C.My heart's electrical cycle is longer than normal.I have brain metastases that have not been treated.I have been treated with MDM2 or p53 therapies before.I have tried at least one PD-1 or PD-L1 inhibitor for my metastatic MCC without success.I can carry out all my usual activities without help.My MCC is p53WT positive according to a certified test.I have had at least one chemotherapy treatment before.I have had a major organ transplant.I have not received any anti-PD-1 or anti-PD-L1 therapy.I have not had chemotherapy before.My MCC is p53WT positive according to a lab test.My Merkel cell carcinoma is confirmed and can be measured.My blood, liver, and kidney functions are all within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2, Arm 2 KRT-232 in combination with avelumab
- Group 2: Cohort 1, Arm 5
- Group 3: Cohort 3
- Group 4: Cohort 4
- Group 5: Cohort 2 Expansion
- Group 6: Cohort 2, Arm 1 KRT-232 in combination with avelumab
- Group 7: Cohort 1 Expansion
- Group 8: Cohort 1, Arm 1
- Group 9: Cohort 1, Arm 1b
- Group 10: Cohort 1, Arm 2b
- Group 11: Cohort 1, Arm 3
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.
What is the overall participant count for this investigation?
"Kartos Therapeutics, Inc. needs 115 participants that match the criteria to begin this experiment across two sites: Fox Chase Cancer Center in Philadelphia, Pennsylvania and Moffitt in Tampa, Colorado."
Answered by AI
How many locations within this state are participating in the clinical trial?
"This research is recruiting participants from various medical establishments, including Fox Chase Cancer Center in Philadelphia, Moffitt in Tampa and University of Colorado Anschutz Medical Campus in Aurora. 16 clinical trial sites are currently participating overall."
Answered by AI
Is recruitment for this experiment still taking place?
"Indeed, clinicaltrials.gov reveals that this investigation is currently recruiting participants. The trial was initiated on March 19th 2019 and last updated on August 3rd 2022; 115 individuals across 16 participating sites are expected to take part in the study."
Answered by AI
What preexisting research exists on the efficacy of KRT-232?
"Currently, 13 active clinical trials are researching KRT-232 with one of those in the final phase. Gif-sur-Yvette is a primary testing site for this medication, but there are 582 other locations conducting experiments regarding KRT-232's efficacy and safety."
Answered by AI
What objectives does this research endeavor hope to accomplish?
"This trial, slated to run for 10 weeks, seeks to evaluate the objective response rate (ORR) of subjects with p53WT MCC that have not responded to anti-PD-1 or anti-PDL-1 immunotherapy. Secondary objectives include measuring the duration of response (DoR), clinical benefit rate (CBR), and progression free survival (PFS)."
Answered by AI
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