Metastatic MelanomaPhase 1NCT03991741

Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors

A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in people with Metastatic Melanoma and Locally Advanced Refractory/Recurrent Melanoma, run by Gregory Daniels at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Melanoma, Locally Advanced Refractory/Recurrent Melanoma, Metastatic Head and Neck Cancer
What is being tested?: Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: 7 Oct 2020to 26 Jan 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients with a histologically confirmed diagnosis of head and neck squamous cell carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
Progressive squamous cell cancer of the head and neck or metastatic melanoma since prior systemic treatment and who are:
Not candidates for known curative intent therapy.
Progressed following at least one prior systemic therapy.
Have advanced melanoma unresectable stage III or stage IV
Have advanced head and neck recurrent or metastatic disease

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Have no more than 3 brain metastases. Note: If lesions are symptomatic or ≥ 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible.
Life expectancy of greater than 3 months.
ECOG Performance Status of 0 or 1.
Adequate organ and marrow function
Seronegative for HIV antibody.
Seronegative for Hepatitis B antigen, or Hepatitis C antibody or antigen.
More than four weeks has elapsed since the patient received any prior systemic therapy at the time of enrollment.
Patient has stable or progressing disease after at least one prior treatment.
Six weeks or more have elapsed since the patient received any prior anti-CTLA4 antibody therapy

Who cannot join

Currently using investigational agents.
Had prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
Patient is a female of child-bearing potential who is pregnant or breastfeeding
Patient requires immune suppressive therapy including but not limited to greater than physiologic steroid replacement.
Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
Patient has any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).

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Patient has opportunistic infections.
Patient has a history of coronary revascularization or ischemic symptoms.
Patients with clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block.

Trial locations and contacts

1 site in 1 country.

United States1 site

UC San Diego Moores Cancer Center
La Jolla, California, 92093

Other trials in United States

About this study

Official title: Phase I Trial of Lymphodepletion Followed by Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors

Read the detailed description

To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells. This is called transfer of autologous (they came from you) tumor infiltrating lymphocytes (the cells that have been grown in the laboratory. Participants getting these cell infusions will also be treated with interleukin-2 (IL-2).

Conditions: Metastatic Melanoma, Locally Advanced Refractory/Recurrent Melanoma, Metastatic Head and Neck Cancer, Locally Advanced Refractory/Recurrent Head and Neck Cancer
Being tested: Autologous Tumor Infiltrating Lymphocytes, High-Dose Interleukin 2
Keywords: melanoma, metastatic, head and neck cancer, solid tumor, adoptive cell therapy, autologous, locally advanced refractory/recurrent melanoma, locally advanced refractory/recurrent head and neck cancer, IL-2
Medical subject headings: Melanoma, Head and Neck Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous Tumor Infiltrating LymphocytesBiological
Autologous TILs
High-Dose Interleukin 2Biological
720,000 IU/kg every 8 hours for up to 15 doses

Study groups in NCT03991741
Study group	Role	What they receive
Solid Tumor	Experimental	Solid Tumor Receives: Biological: Autologous Tumor Infiltrating Lymphocytes; Biological: High-Dose Interleukin 2

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose Limiting Toxicity
Dose Limiting Toxicity (DLT)
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 202026 Jan 2023

First posted19 Jun 2019
Study start7 Oct 2020
Primary completion26 Jan 2023
Study completion26 Jan 2023

Why it stopped: Closed because of feasibility and safety issues, didn't reach our end point

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Metastatic 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03991741
Sponsor's protocol ID: 160710
Status last verified: Jun 2025
First submitted: 10 Apr 2019
Last updated: 3 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 1/2
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Unresectable or Metastatic Melanoma

All Metastatic Melanoma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Trial of Lymphodepletion Followed by Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
ClinicalTrials.gov ID: NCT03991741
Acronym / sponsor ID: 160710
Conditions: Metastatic Melanoma, Locally Advanced Refractory/Recurrent Melanoma, Metastatic Head and Neck Cancer, Locally Advanced Refractory/Recurrent Head and Neck Cancer
Keywords: melanoma, metastatic, head and neck cancer, solid tumor, adoptive cell therapy, autologous, locally advanced refractory/recurrent melanoma, locally advanced refractory/recurrent head and neck cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Closed because of feasibility and safety issues, didn't reach our end point
Enrolment: 3 participants (actual)
Lead sponsor: Gregory DanielsUniversity, hospital or other
Collaborators: Immunotherapy Foundation
Study start: 7 Oct 2020 (actual)
Primary completion: 26 Jan 2023 (actual)
Study completion: 26 Jan 2023 (actual)
First posted: 19 Jun 2019 (actual)
Results: Posted 3 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Solid Tumor	Experimental	Biological: Autologous Tumor Infiltrating Lymphocytes, Biological: High-Dose Interleukin 2Solid Tumor

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Patients with a histologically confirmed diagnosis of head and neck squamous cell carcinoma OR metastatic cutaneous or mucosal melanoma measurable per RECIST.
Progressive squamous cell cancer of the head and neck or metastatic melanoma since prior systemic treatment and who are:
Have no more than 3 brain metastases. Note: If lesions are symptomatic or ≥ 1 cm each, these lesions must have been treated and stable for 3 months for the patient to be eligible.
Life expectancy of greater than 3 months.
ECOG Performance Status of 0 or 1.

Key exclusion criteria (9 listed)

Currently using investigational agents.
Had prior cell transfer therapy which included a non-myeloablative or myeloablative chemotherapy regimen.
Patient is a female of child-bearing potential who is pregnant or breastfeeding
Patient requires immune suppressive therapy including but not limited to greater than physiologic steroid replacement.
Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary 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
Autologous Tumor Infiltrating LymphocytesAutologous TILs	Biological	Solid Tumor
High-Dose Interleukin 2720,000 IU/kg every 8 hours for up to 15 doses	Biological	Solid Tumor

Primary outcome

Dose Limiting Toxicity
Time frame: 2 months
Dose Limiting Toxicity (DLT)

Results and safety

Results posted to the registry on 3 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Solid Tumor	3	3

Primary outcome: Dose Limiting Toxicity

Time frame: 2 months. Count of participants. Unit: Participants

Measure	Solid Tumor n = 3
Blood and Lymphatic System Disorders	1
Immune System Disorders, Renal and Urinary Disorders	1
Infections and Infestations, Endocrine Disorders, Metabolism and Nutrition Disorders, Investigations	1

Adverse events

Time frame: 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Solid Tumor	3 of 3 (100%)	3 of 3 (100%)	3 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Metastatic Melanoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 1/2
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Unresectable or Metastatic Melanoma

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.

Gregory Daniels, MD, PhD principal investigator

University of California, San Diego

Ezra Cohen, MD principal investigator

University of California, San Diego

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 9 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dose Limiting Toxicity (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03991741.

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 3 Jul 2025.