Advanced Cutaneous MelanomaPhase 2DELTA-1NCT05050006
ITIL-168 in Advanced Melanoma
A Phase 2 study testing ITIL-168 in people with Advanced Cutaneous Melanoma, run by Instil Bio at 22 sites in 3 countries.
Trial summary
DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cutaneous Melanoma
- What is being tested?
- ITIL-168
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 7 Oct 2021to 27 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed advanced (unresectable or metastatic) cutaneous melanoma.
- Cohort 1: Disease that is relapsed after or refractory to at least 1 prior line of systemic therapy that must include a PD-1 inhibitor and, if positive for proto- oncogene BRAF V600 activating mutation, targeted therapy.
- Cohort 2: Disease that is persistent after discontinuing PD-1 due to toxicity. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
- Cohort 3: Disease that is stable (SD) after at least 4 doses of a PD-1 inhibitor. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
- Medically suitable for surgical resection of tumor tissue
- Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow and organ function
Who cannot join
- History of another primary malignancy within the previous 3 years
- Melanoma of uveal, acral, or mucosal origin
- Previously received an allogeneic stem cell transplant or organ allograft
- Previously received TIL or engineered cell therapy ( eg, CAR T-cell)
- Significant cardiac disease
- Stroke or transient ischemic attack within 12 months of enrollment
Show all 10Show fewer
- History of significant central nervous system (CNS) disorder
- Symptomatic and/or untreated CNS metastases
- History of significant autoimmune disease within 2 years prior to enrollment
- Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, or IL-2.
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United States20 sites
University of Colorado - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rush University Cancer Center
Chicago, Illinois, 60612
Cleveland Clinic - Taussig Cancer Center
Cleveland, Ohio, 44195
University of California San Diego, Moores Cancer Center
La Jolla, California, 92093
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
USC - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA Health - Westwood Cancer Care
Los Angeles, California, 90095
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, 40202
Loyola University Chicago
Maywood, Illinois, 60153
The University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455
Atlantic Health System - Morristown Medical Center
Morristown, New Jersey, 07962
Orlando Health Cancer Institute
Orlando, Florida, 32806
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Stanford Cancer Institute
Stanford, California, 94305
Moffitt Cancer Center
Tampa, Florida, 33612
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
United Kingdom1 site
Cambridge University Hospital NHS Foundation Trust - Addenbrooke's Hospital
Cambridge, England, CB2 0QQ
About this study
Official title: A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects With Advanced Melanoma (DELTA-1)
DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).
- Conditions
- Advanced Cutaneous Melanoma
- Being tested
- ITIL-168
- Keywords
- ITIL-168, Cell Therapy, melanoma, Autologous cell therapy, Cellular Immunotherapy, TIL, Autologous Adoptive Cell Transfer, Immuno-oncology, IL-2, Autologous Adoptive Cell Therapy, Tumor Infiltrating Lymphocytes, T-cell therapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITIL-168Biological
ITIL-168 is a cell therapy product derived from a patient's own TILs. A tumor sample is removed from each patient to make a personalized ITIL-168 product. Once ITIL-168 has been made, the patient is treated with 5 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by a single infusion of ITIL-168, and up to 8 doses of IL-2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients who relapsed after or were refractory to at least 1 prior line of systemic therapy including a PD-1 inhibitor. Receives: Biological: ITIL-168 |
| Cohort 2 | Experimental | Patients who were intolerant to a PD-1 inhibitor and have persistent disease after stopping PD-1 therapy. Receives: Biological: ITIL-168 |
| Cohort 3 | Experimental | Patients who had a best response of stable disease despite being treated with at least 4 doses of a PD-1 inhibitor in the previous line of therapy. Receives: Biological: ITIL-168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate (ORR), defined as the incidence of a complete response (CR) or a partial response (PR) per a modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria, as assessed by central review.
Measured: Up to 60 months
Secondary outcomes (8)
Duration of Response
For subjects who experience an objective response, duration of response (DOR) is defined as the time from their first objective response to disease progression or death.
Measured: Up to 60 months
Progression-free Survival
Progression-free survival (PFS) is defined as the time from the ITIL-168 infusion date to the date of disease progression or death from any cause.
Measured: Up to 60 months
Overall Survival
Overall survival (OS) is defined as the time from the ITIL-168 infusion date to the date of death from any cause.
Measured: Up to 60 months
ORR as determined by investigators
ORR as determined by investigators is defined as the incidence of a CR or a PR per a modified RECIST v1.1, as determined by study investigators.
Measured: Up to 60 months
Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
Measured: Up to 60 months
Disease Control Rate
Disease control rate (DCR), defined as the incidence of CR, PR, or stable disease (SD) per a modified RECIST v1.1 criteria, as determined by central review.
Measured: Up to 60 months
Best Overall Response
Measured: Up to 60 months
Time to Response
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start7 Oct 2021
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Cutaneous MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All enrolled participants are assigned to be treated with a single dose of ITIL-168
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instil Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Instil Study Director, Study director, Instil Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050006
- Sponsor's protocol ID
- ITIL-168-101
- Other IDs
- 2020-003862-37
- Acronym
- DELTA-1
- Status last verified
- Apr 2024
- First submitted
- 9 Sep 2021
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects With Advanced Melanoma (DELTA-1)
- ClinicalTrials.gov ID
- NCT05050006
- Acronym / sponsor ID
- DELTA-1 / ITIL-168-101
- Conditions
- Advanced Cutaneous Melanoma
- Keywords
- ITIL-168, Cell Therapy, melanoma, Autologous cell therapy, Cellular Immunotherapy, TIL, Autologous Adoptive Cell Transfer, Immuno-oncology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Instil BioIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All enrolled participants are assigned to be treated with a single dose of ITIL-168
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: ITIL-168Patients who relapsed after or were refractory to at least 1 prior line of systemic therapy including a PD-1 inhibitor. |
| Cohort 2 | Experimental | Biological: ITIL-168Patients who were intolerant to a PD-1 inhibitor and have persistent disease after stopping PD-1 therapy. |
| Cohort 3 | Experimental | Biological: ITIL-168Patients who had a best response of stable disease despite being treated with at least 4 doses of a PD-1 inhibitor in the previous line of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed advanced (unresectable or metastatic) cutaneous melanoma.
- Cohort 1: Disease that is relapsed after or refractory to at least 1 prior line of systemic therapy that must include a PD-1 inhibitor and, if positive for proto- oncogene BRAF V600 activating mutation, targeted therapy.
- Cohort 2: Disease that is persistent after discontinuing PD-1 due to toxicity. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
- Cohort 3: Disease that is stable (SD) after at least 4 doses of a PD-1 inhibitor. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
- Medically suitable for surgical resection of tumor tissue
Key exclusion criteria (10 listed)
- History of another primary malignancy within the previous 3 years
- Melanoma of uveal, acral, or mucosal origin
- Previously received an allogeneic stem cell transplant or organ allograft
- Previously received TIL or engineered cell therapy ( eg, CAR T-cell)
- Significant cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITIL-168ITIL-168 is a cell therapy product derived from a patient's own TILs. A tumor sample is removed from each patient to make a personalized ITIL-168 product. Once ITIL-168 has been made, the patient is treated with 5 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by a single infusion of ITIL-168, and up to 8 doses of IL-2. | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Objective response rate
Time frame: Up to 60 months
Objective response rate (ORR), defined as the incidence of a complete response (CR) or a partial response (PR) per a modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria, as assessed by central review.
8 secondary outcomes
Duration of Response
Time frame: Up to 60 months
Progression-free Survival
Time frame: Up to 60 months
Overall Survival
Time frame: Up to 60 months
ORR as determined by investigators
Time frame: Up to 60 months
Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
Time frame: Up to 60 months
Disease Control Rate
Time frame: Up to 60 months
Best Overall Response
Time frame: Up to 60 months
Time to Response
Time frame: Up to 60 months
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Instil Study Director study director
Instil Bio, Inc.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ITIL-168 in people with Advanced Cutaneous Melanoma, run by Instil Bio at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.