Your session is about to expire
← Back to Search
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 2 weeks
Treatment 24 months
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial has 2 phases. The first is to check for side effects and the second is to see if the treatment improves symptoms.
Eligible Conditions
- Melanoma
- Tumors
Timeline
Screening ~ 2 weeks2 visits
Treatment ~ 24 months60 visits
Follow Up ~ 8 weeks0 visits
Screening ~ 2 weeks
Treatment ~ 24 months
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting one or More Serious Adverse Event (SAEs)
Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Dose Limiting Toxicities (DLTs)
+3 moreSecondary outcome measures
Phase 1b and Phase 2 Safety Lead-in: AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
Phase 1b and Phase 2 Safety Lead-in: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Modakafusp Alfa
Phase 1b and Phase 2 Safety Lead-in: CL: Total Clearance After Intravenous Administration for Modakafusp Alfa
+23 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
5Treatment groups
Experimental Treatment
Group I: Phase 2 Safety Lead-in Dose Expansion: Modakafusp Alfa + PembrolizumabExperimental Treatment2 Interventions
Melanoma with primary resistance to prior anti-PD1, acquired resistance to prior anti-PD1 or naïve to anti-PD1.
Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years. The starting dose of modakafusp alfa for dose expansion safety lead-in phase will be the RP2D determined in the previous Phase 1b dose escalation phase.
Group II: Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma naïve to anti-PD1)Experimental Treatment2 Interventions
Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma naive to prior line of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety lead-in phase.
Group III: Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma With Primary Resistance)Experimental Treatment2 Interventions
Melanoma With Primary Resistance to prior anti-PD1. Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety-lead in phase.
Group IV: Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma With Acquired Resistance)Experimental Treatment2 Interventions
Melanoma With Acquired Resistance to prior anti-PD1. Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety lead-in phase.
Group V: Phase 1b SA Dose EscalationExperimental Treatment1 Intervention
Modakafusp alfa 0.1 to 6 milligram per kilogram (mg/kg), infusion, intravenously, once on Day 1 of each 21-days treatment cycle for up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,148 Total Patients Enrolled
1 Trials studying Melanoma
27 Patients Enrolled for Melanoma
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,566 Total Patients Enrolled
5 Trials studying Melanoma
1,580 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an autoimmune disease that requires medication to suppress your immune system. However, if you have an immune-related hormone deficiency that is stable and being treated with hormone replacement therapy, you may still be eligible.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma naïve to anti-PD1)
- Group 2: Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma With Primary Resistance)
- Group 3: Phase 1b SA Dose Escalation
- Group 4: Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma With Acquired Resistance)
- Group 5: Phase 2 Safety Lead-in Dose Expansion: Modakafusp Alfa + Pembrolizumab
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 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 24 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 8 Weeks after you stop receiving the treatment.
Melanoma Patient Testimony for trial: Trial Name: NCT04157517 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has recruitment for this research been successful?
"For this clinical trial, Takeda is seeking a total of 114 qualified patients. The study will be conducted at multiple sites, such as the University of California San Diego Moores Cancer Center in La Jolla, CA and The Angeles Clinic and Research Institute - West Los Angeles Office in Los Angeles, TX."
Answered by AI
In what geographic areas is this research taking place?
"With 15 medical sites spread across the country, this study is currently ongoing. Notable cities include La Jolla, Los Angeles and Dallas among others; participants should thus select a clinic that best suits their geographic needs in order to minimize travel requirements."
Answered by AI
What are common indications for Modakafusp Alfa?
"Modakafusp Alfa is widely utilized to manage malignant neoplasms and has also been successfully employed in cases of unresectable melanoma, microsatellite instability high, or chemotherapy-induced disease progression."
Answered by AI
Are there still openings available for this clinical experiment?
"Data posted on clinicaltrials.gov reveals that the recruitment of participants is currently underway for this medical trial, which was initially published back in December 12th, 2019 and updated most recently on November 22nd 2022."
Answered by AI
What prior researches have been conducted regarding Modakafusp Alfa?
"Modakafusp Alfa was first considered in a research setting at City of Hope back in 2010, with 251 studies being completed since then. At present there are 962 trials still running, many of which are situated within La Jolla, California."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Texas Oncology - Baylor Charles A. Sammons Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
This is in line with my diagnosis which would help me confront my problems. Previous meds don't really wirk. What can I do to be chosen?
PatientReceived 1 prior treatment
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger