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LNS8801 + Pembrolizumab for Cancer
Study Summary
This trial is testing a new drug, LNS8801, to see if it is safe and works well against cancer. Up to 200 patients will be enrolled at up to 10 sites in the United States.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have an immune system disorder or have been on strong immune-weakening medication recently.I agree to a biopsy if my tumor can be safely accessed.I haven't had cancer treatment in the last 4-6 weeks, except for specific immunotherapies.I am not currently breastfeeding.I have pancreatic, gastric, NSCLC, or colorectal cancer.My cancer progressed despite having multiple treatments with anti-PD-1/L1 therapy.My cancer can be measured on scans, and has grown even after radiation.I am not pregnant, confirmed by recent tests.My NSCLC has a PD-L1 score of 1-49%, no EGFR or ALK changes, and I haven't had PD-1/L1 blockers.I have no standard treatment options available or I choose not to pursue them.My cancer is confirmed to be advanced or has spread to other parts.You can read and understand the information provided to you about the study and willingly agree to participate while following the study guidelines.I am willing to use effective birth control during and for 4 months after the study.I have melanoma, had severe side effects from anti-PD-1/L1 therapy, and haven't had other cancer treatments since.I am a male willing to use effective contraception or am surgically sterile.I have uveal melanoma with metastasis and have had 2 or fewer previous treatments.I have side effects from cancer treatment that haven't fully gone away, except for hair loss.I've had small-area radiation for symptom relief recently, not affecting over 30% of my bone marrow, and have recovered from side effects.I do not have any active infections needing treatment.My heart's electrical cycle is within a safe range, and I don't use medications that could disrupt it.I need or have recently had anti-TNF therapy like infliximab.I have a condition that affects how my body absorbs medication.I haven't had another active cancer besides my current one in the last 2 years, except for certain low-risk types or skin cancers.My blood counts and liver/kidney functions are within safe ranges for treatment.My cancer worsened after initially responding to anti-PD-1/L1 treatment without any other treatments in between.I have skin cancer (melanoma).I have not had major surgery in the last 4 weeks.I have received an organ or tissue transplant from another person.I had severe side effects from previous anti-PD-1/L1 therapy for my cancer and haven't had any other cancer treatment since.I have uveal melanoma with metastasis and have had 2 or fewer previous treatments.My cancer is advanced or has spread to other parts of my body.I am using, or have used, estrogen hormone replacement therapy since my diagnosis.I am not in another study and haven't used experimental treatments in the last 4 weeks.I have symptoms from a brain tumor or cancer spread to my brain or spinal cord.You are not currently participating in or have recently participated in another experimental treatment within the last month or 5 half-lives, whichever is shorter.I have skin cancer, was treated with anti-PD-1/L1, had severe side effects, and haven't had other cancer treatments since.I have lung inflammation or scarring.I am taking medication that affects liver enzymes.I stopped a cancer immunotherapy due to severe side effects.I have HIV, hepatitis B, or hepatitis C.I have an autoimmune disease treated with strong medication in the last 2 years.My cancer is confirmed to be advanced or has spread to other parts.I need medication for stomach acid.I can swallow pills.My cancer is known to be estrogen receptor-positive.I have thyroid or gall bladder cancer.I am fully active or restricted in physically strenuous activity but can do light work.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I have not used specific hormone treatments for my current cancer, but I may have used birth control pills.You are expected to meet the specific requirements to participate in the study.I have taken estrogen or estrogen-based contraceptives since my cancer diagnosis.My cancer was treated with hormone therapy targeting estrogen.I've had lung radiation over 30 Gy in the last 6 months.I have pancreatic, gastric, lung, or colorectal cancer.You are expected to live for at least three more months.I do not have any severe illnesses that my doctor says are uncontrolled.
- Group 1: Active
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is this an experimental treatment or has it been studied before?
"1000 different medical studies are currently underway to research this intervention. 122 of those trials have reached Phase 3 and the majority of them are based in Houston, Texas. However, there are 36030 total locations running these sorts of trials."
How many people are included in the total sample size for this research?
"That is accurate. The information available on clinicaltrials.gov reveals that this research project is presently looking for volunteers. This trial was originally posted on October 21st, 2019 and was most recently edited on April 13th, 2022. A total of 200 individuals are needed at 8 different locations."
Are there any positions available for participants in this research?
"That is correct. The information available on clinicaltrials.gov affirms that this trial, which was first advertised on October 21st 2019, is still recruiting patients. In total, they are hoping to enroll 200 individuals from 8 different medical facilities."
What are the common reasons that patients receive this medication?
"This therapeutic intervention is most frequently used to ameliorate the effects of malignant neoplasms. In addition, it has been found to be an effective treatment for unresectable melanoma, microsatellite instability high and disease progression after chemotherapy."
Are there different test sites for this experiment located throughout Canada?
"To limit travel-related stressors, patients are encouraged to choose the recruitment site that is closest to them. Currently, there are 8 sites enrolling individuals in this study: these locations include Philadelphia, San Antonio and Albuquerque amongst others."
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