An observational study in Melanoma, Gastrointestinal Cancer and Metastatic Cancer, sponsored by National Cancer Institute (NCI). Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by National Cancer Institute (NCI) · Observational
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Among 211 studies in Melanoma by National Cancer Institute (NCI) — 14 open to participants now, 38 under way, 4 of them phase 3. Melanoma · National Cancer Institute (NCI).
Among the 211 studies in Melanoma by National Cancer Institute (NCI), this one is the 5th largest by planned enrollment of the 20 observational ones that give a count, is one of 12 that started in 2003, is one of 20 observational ones, and was the 51st registered.
3,372 studies on the registry are indexed under Melanoma; 580 are open to participants now.
Browse Melanoma studies →14 of the 211 studies in Melanoma by National Cancer Institute (NCI) are open now, in 1 country. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
National Cancer Institute (NCI) · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18–120
National Cancer Institute (NCI) · Sites in United States
Ages 18–72
By country, each count listing its studies:
Of the 468 Melanoma studies recruiting now, 381 (81%) set no upper age limit and 49 (10%) stop at 75 or younger; 47 take children under 18; 29 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
211 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 68 · Phase 2 134 · Phase 3 10
First in 1992; this study’s year is marked. 12 started in 2003.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 7,000 is above the median of 187 across 489 observational studies indexed under Melanoma.
Median enrollment 32 across the 165 interventional studies, 1,654 across the 20 observational. Of the 165 that completed or were terminated, 74 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 412 completed or terminated interventional studies of FDA-regulated products, 374 (91%) have results posted.
7 of the studies in Melanoma by National Cancer Institute (NCI) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04708418National Cancer Institute (NCI)A Study Evaluating Whether Pembrolizumab Alone or in Combination With CMP-001 Improves Efficacy of Treatment in Patients With Operable Melanoma | 2026-12-31 |
| NCT05136196National Cancer Institute (NCI)BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study | 2027-01-01 |
| NCT06066138National Cancer Institute (NCI)A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing | 2027-01-31 |
| NCT02196181National Cancer Institute (NCI)Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread | 2027-03-15 |
| NCT04314401National Cancer Institute (NCI)National Cancer Institute "Cancer Moonshot Biobank" | 2027-04-30 |
Add all 7 to your calendar (.ics) → With an account.
Among the 211 studies in Melanoma by National Cancer Institute (NCI), from their registry updates:
This tab as a report to print or save as PDF → With an account.
Background:
The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
Objective:
This study will collect white blood cells from normal volunteers and white blood cells and/or tumor cells, from patients who have been screened for and are eligible for a NCI Surgery Branch treatment protocol. The cells collected from normal volunteers will be used as growth factors for the cells during the period of laboratory growth. The cells and/or tumor from patients will be used to make the cell treatment product.
Eligibility:
Patients must be eligible for a NCI Surgery Branch Treatment Protocol
Normal Volunteers must meet the criteria for blood donation
Design
Both patients and normal Volunteers will undergo apheresis. Patients will then undergo further testing as required by the treatment protocol.
There is no required follow up for normal volunteers.
...
Background:
There are numerous clinical trials underway in the National Cancer Institute Surgery Branch (NCI-SB) in which patients are administered autologous lymphocytes with anti-tumor activity generated from either peripheral blood mononuclear cells (PBMC) or tumor-infiltrating lymphocytes (TIL). All adoptive cell therapy protocols require that certain cell criteria be evaluated and met prior to enrollment.
This protocol is also designed to serve as a biorepository for samples and associated data collected on patients enrolled on NCI-SB protocols, current and historical. Patients who were enrolled prior to 2003 were not enrolled on this protocol. Their tissue and data will now be retained on this protocol for long-term storage. The protocol is concerned with the retention of serum, CSF, bone marrow, ascites fluid, PBMCs, tumor, healthy tissue samples, and CD34 purified HSCS samples collected from patients with cancer to support basic science and clinical research activities of the NCI-SB at the NIH Clinical Research Center and Center for Cancer Research.
Objectives:
To obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancer for laboratory analysis and ex vivo generation of autologous anti-tumor lymphocytes for potential future enrollment on an NCI-SB adoptive cell therapy clinical trial.
To obtain allogeneic PBMC via apheresis, whole blood, or other blood products from healthy volunteers, for use in generating anti-tumor patient lymphocytes ex vivo.
To conduct genomic, proteomic, and immunologic research studies on samples collected from patients with a current diagnosis of cancer.
Eligibility:
Patients with cancer must be >= 18 years of age and meet the laboratory safety testing for infection included in all treatment trials.
Healthy volunteers for PBMC donation must meet the safety evaluation criteria established by the FDA for donation of blood products. They must also meet the strict behavioral and medical history requirements.
Healthy volunteers for whole blood donation must meet the safety evaluation criteria established by the NIH Clinical Center Department of Transfusion Medicine (DTM) Blood Bank for screening of allogeneic whole blood donors.
Design:
Once a cancer patient is determined to be a potential candidate for one of the NCI-SB clinical trials, they will undergo an apheresis and/or tumor resection for future treatment and/or research purposes. In addition, this protocol will allow for the apheresis of healthy volunteers for allogeneic PBMC or donation of whole blood for processing into serum for use in generating autologous anti-tumor lymphocytes in the laboratory, or for research purposes.
No treatments, investigational or standard therapy, will be administered on this protocol.
Patients with a current diagnosis of cancer who are 18 years of age or older - Healthy volunteers who are 18 years of age or older and meet the safety evaluation criteria established by the FDA for donation of blood products, or, meet the safety evaluation criteria established by the NIH Clinical Center Department of Transfusion Medicine (DTM) Blood Bank for screening of allogeneic whole blood donors
INCLUSION CRITERIA:
Serology
EXCLUSION CRITERIA:
ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS:
INCLUSION CRITERIA for PBMC Donors:
INCLUSION CRITERIA FOR WHOLE BLOOD DONORS:
EXCLUSION CRITERIA for PBMC Donors:
EXCLUSION CRITERIA for Whole Blood Donors:
- Whole blood donors who do not meet the DTM criteria for allogeneic whole blood donation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a current diagnosis of cancer
Drug: Anti-CD19 CAR PBL
Healthy volunteers
Generating anti-tumor patient lymphocytes ex vivo
Obtain allogeneic PBMC via apheresis, whole blood, or other blood products from healthy volunteers, for use in generating anti-tumor patient lymphocytes ex vivo.
Time frame: Approximately 20 years
To conduct genomic, proteomic, and immunologic research studies
Conduct genomic, proteomic, and immunologic research studies on samples collected from patients with a current diagnosis of cancer.
Time frame: Approximately 20 years
To obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancer
Obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancer for laboratory analysis and ex vivo generation of autologous anti-tumor lymphocytes for potential future enrollment on an NCI-SB adoptive cell therapy clinical trial.
Time frame: Approximately 20 years
Repository of specimens and associated data
Repository for specimens and associated data obtained on patients enrolled on NCI-SB protocols who were not consented on this protocol.
Time frame: Approximately 20 years
Long-term storage of data and biospecimens
Long-term storage of data and biospecimens collected during prospective clinical trials in patients with various cancer phenotypes, to support the research activities of the NCI-SB.
Time frame: Approximately 20 years
Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Clinical data will be available during the study and indefinitely. @@@@@@Genomic data will be available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@Genomic data will be made available via dbGaP through requests to the data custodians.
Started Sep 2003 (actual).
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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National Cancer Institute (NCI) →