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Tyrosine Kinase Inhibitor
AL3818 + Nivolumab for Cancer
Phase 1 & 2
Waitlist Available
Led By Sant P Chawla, MD
Research Sponsored by Sarcoma Oncology Research Center, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate baseline function within 28 days prior to enrollment: Bone marrow function: Absolute neutrophil count (ANC) ≥ 1,500/mm3; platelets ≥ 100,000/mm3 , Hemoglobin ≥ 9.0 g/dL. Renal function: Creatinine clearance (calculated by Cockcroft-Gault) must be ≥ 30 ml/min. Hepatic function: Bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3.0 x ULN for subjects with Gilbert Syndrome; AST and ALT ≤ 3.0 × ULN. Coagulation profile: International normalized ratio (INR) is ≤ 2.0; absolute prothrombin time (aPTT) < 1.5 x ULN. Left ventricular ejection fraction (LVEF) of > 50% by ECHO or MUGA within 56 days prior to enrollment. Two blood pressure readings with systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg at screening with 28 days prior to enrollment. Provide written informed consent before any study-specific procedures are initiated.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combining two drugs, to see if it is safe and effective.
Who is the study for?
This trial is for adults with certain advanced solid tumors, including lung cancer and sarcoma, who've had at least one previous treatment. They must have a good performance status (able to carry out daily activities), proper organ function, controlled blood pressure, no major recent surgeries or untreated brain metastases, and not be on immunosuppressants.Check my eligibility
What is being tested?
The study tests AL3818 combined with Nivolumab in patients with advanced solid tumors. It has two parts: first to find the best dose of AL3818 when used with Nivolumab; second to check how safe and effective this combination is in treating different types of cancers like soft tissue sarcoma and lung cancer.See study design
What are the potential side effects?
Possible side effects include high blood pressure, bleeding risks, heart issues like angina or heart attacks within the past six months. There's also a risk of immune-related problems due to Nivolumab affecting organs like lungs or intestines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
Select...
My cancer has returned or spread and needs treatment, or there's no standard treatment for it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rates (ORR) - Part 2 (Phase 2a)
Recommended Phase 2 Dose (RP2D) - Part 1 (Phase 1b)
Secondary outcome measures
Clinical Benefit Rate (CBR) - Part 2 (Phase 2a)
Duration of Response (DOR) - Part 2 (Phase 2a)
Overall Survival (PFS) - Part 2 (Phase 2a)
+1 moreOther outcome measures
Incidence of Treatment-Emergent Adverse Events - Parts 1 and 2
Trial Design
1Treatment groups
Experimental Treatment
Group I: AL3818 plus nivolumabExperimental Treatment2 Interventions
Part 1: All participants will be assigned to receive AL3818 capsules orally, once daily at sequential deescalating doses (on treatment Days 1-14 followed by no AL3818 treatment from Days 15-21) in combination with nivolumab injection treatment (on Day 1 and Day 15) for a single 21-day cycle. Participants may continue study treatment at the AL3818 cohort dose at investigator discretion.
Part 2: All participants will receive AL3818 capsules orally, once daily at the RP2D determined from Part 1 (on treatment Days 1-14 followed by no AL3818 treatment from Days 15-21) in combination with nivolumab injection treatment (every 2 weeks starting on Cycle 1, Day 1) in 21-day cycles, for up to 24 cycles of total AL3818 therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab Injection
2017
Completed Phase 2
~410
Find a Location
Who is running the clinical trial?
Sarcoma Oncology Research Center, LLCLead Sponsor
7 Previous Clinical Trials
510 Total Patients Enrolled
Advenchen Laboratories, LLCIndustry Sponsor
4 Previous Clinical Trials
631 Total Patients Enrolled
Sant P Chawla, MDPrincipal InvestigatorSarcoma Oncology Research Center
6 Previous Clinical Trials
428 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any autoimmune or lung diseases.I am able to care for myself and perform daily activities.My cancer has spread to the lining of my brain and spinal cord.My condition worsened or came back within the last 6 months.I have hepatitis C and haven't completed treatment, with a detectable viral load.I have had a blood clot in my veins that was not treated in the last 6 months.I have no conditions that affect my ability to take or absorb medications.I haven't taken steroids or immunosuppressants in the last 14 days.I have HIV with a CD4+ count below 350 cells/uL.I have an infection that is not responding to treatment.I have had an organ transplant.I do not have active stomach ulcers or serious gut conditions, and I haven't had a gut perforation or abscess in the last month.It has been over 3 weeks since my last cancer treatment.I haven't had major heart or stroke issues in the last 6 months.I have severe heart failure.I have a wound, fracture, or ulcer that hasn't healed, or I have symptoms of peripheral vascular disease.I haven't had significant bleeding or blood clotting issues in the last 6 months.I have chronic hepatitis B or C with a detectable viral load.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.You have a known allergy or severe reaction to protein-based treatments or any major drug allergy in the past.Your heart's electrical activity (measured by an ECG) shows a longer than normal QT interval.I have another type of cancer that could affect this study's treatment.You have a disease that can be measured using a specific set of guidelines.I have AIDS and had an opportunistic infection in the last year.I have untreated brain metastases.I have STS, SCLC, or NSCLC and need treatment after my first one.My cancer has returned or spread and needs treatment, or there's no standard treatment for it.
Research Study Groups:
This trial has the following groups:- Group 1: AL3818 plus nivolumab
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.
Are there other examples of research using AL3818?
"There are 830 ongoing clinical trials that involve AL3818. Of these, 89 are Phase 3 studies. The vast majority of research is being conducted in Zürich, BE; however, there are 40560 locations running similar studies."
Answered by AI
What is the maximum sample size for this experiment?
"That is correct. The online information from clinicaltrials.gov affirms that this trial, which was first announced on October 17th 2019, is presently recruiting patients. They are looking for 56 individuals total, who will be drawn from 1 site."
Answered by AI
What conditions does AL3818 typically alleviate?
"AL3818 is a medication that oncologists often prescribe to treat malignant neoplasms. However, it can also palliate symptoms for patients suffering from unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
Are new participants being taken in for this research?
"That is accurate. The information available on clinicaltrials.gov affirms that this trial, which was initially posted on October 17th 2019, is looking for 56 patients from a single site."
Answered by AI
Is this a fresh approach to testing?
"AL3818 has been under clinical investigation for a decade. In 2010, the first study was conducted by Medarex and involved 127 patients. The success of this initial Phase 1 trial led to the drug's approval. Currently, 830 different trials are ongoing in 2372 cities across 50 nations."
Answered by AI
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