MelanomaNCT00068003
Harvesting Cells for Experimental Cancer Treatments
An observational study of Melanoma and Gastrointestinal Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Gastrointestinal Cancer, Metastatic Cancer
- What is being tested?
- Anti-CD19 CAR PBL
- How many people
- 7,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2003to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- Patients must have a form of cancer currently being studied in the NCI-SB.
- Patient is able to understand and willing to sign a written informed consent document.
- Age greater than or equal to 18 years.
- Clinical performance status of ECOG 0 or 1.
- Serology
- Seronegative for HIV antibody. (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities).
Show all 13Show fewer
- Seronegative for hepatitis B surface antigen and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
- Lesions which will be harvested for the generation of TIL should be accessible via standard surgical or radiological techniques and be associated with acceptable morbidity.
- Age greater than or equal to 18 years.
- Non-reactive for HBsAg, anti-HBc, anti-HCV, anti-HIV-1/2, HBV/HCV/HIV-1 NAT, anti-HTLV-I/II, anti-T. cruzi, West Nile Virus NAT,syphilis, and babesia.
- PBMC donors must meet the strict behavioral and medical history requirements as per applicable NCI-SB Apheresis Donor SOP(s).
- Age greater than or equal to 18 years.
- Whole blood donors must meet the DTM inclusion criteria for allogeneic whole blood donation.
Who cannot join
- Active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system.
- Patients who cannot give proper informed consent to the experimental therapy due to an active psychiatric disorder or inability to understand the nature of the proposed therapy and attendant risk.
- Women of child-bearing potential who are pregnant because of the potentially dangerous effects of some of the procedures (e.g., tumor biopsy or surgery for tumor resection) on the fetus.
- ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS:
- Has had babesiosis.
- Is at risk or has Creutzfeldt-Jakob Disease.
Show all 20Show fewer
- Is on steroid therapy or any other medication or has received vaccination that might interfere with cell preparation per Principal Investigator s (PI) discretion.
- Has ongoing illness that would cause harm to the volunteer during the apheresis procedure as determined by the PI.
- Has had yellow jaundice, liver disease, or hepatitis since the age of 11.
- Has uncontrolled diabetes.
- Has a hematologic malignancy or any bleeding abnormalities.
- Has received any type of organ transplant in the past 12 months.
- Has undergone xenotransplantation at any time.
- Has received a dura mater graft.
- If female, is pregnant or has given birth within the last six weeks.
- Has had an ear or body piercing or tattoos within the past 12 months.
- Has had a blood transfusion within the past 12 months.
- Has spent time outside the United States to a restricted country.
- Has participated in any high-risk activities.
- Whole blood donors who do not meet the DTM criteria for allogeneic whole blood donation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Cell Harvest and Preparation for Surgery Branch Treatment Protocols
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.
Read more
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.
...
Read the detailed description
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.
- Conditions
- Melanoma, Gastrointestinal Cancer, Metastatic Cancer, Breast Cancer, Non-Small Cell Lung Cancer
- Being tested
- Anti-CD19 CAR PBL
- Keywords
- Adoptive Cell Therapy, Screening, Cell Harvest, Blood, Tumor Tissue, Natural History
- Medical subject headings
- Melanoma, Gastrointestinal Neoplasms, Neoplasm Metastasis, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD19 CAR PBLDrug
| Study group | Role | What they receive |
|---|---|---|
| 1/Cancer Patients | Patients with a current diagnosis of cancer Receives: Drug: Anti-CD19 CAR PBL | |
| 2/Healthy Volunteers | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Approximately 20 years
Secondary outcomes (2)
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.
Measured: 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.
Measured: Approximately 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2003 (estimated)
- Study start8 Sep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Steven A Rosenberg, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00068003
- Sponsor's protocol ID
- 030277
- Other IDs
- 03-C-0277
- Status last verified
- 13 Oct 2026
- First submitted
- 4 Sep 2003
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Dudley ME, Wunderlich JR, Robbins PF, Yang JC, Hwu P, Schwartzentruber DJ, Topalian SL, Sherry R, Restifo NP, Hubicki AM, Robinson MR, Raffeld M, Duray P, Seipp CA, Rogers-Freezer L, Morton KE, Mavroukakis SA, White DE, Rosenberg SA. Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes. Science. 2002 Oct 25;298(5594):850-4. doi: 10.1126/science.1076514. Epub 2002 Sep 19.
PubMed 12242449Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA Jr, Kinzler KW. Cancer genome landscapes. Science. 2013 Mar 29;339(6127):1546-58. doi: 10.1126/science.1235122.
PubMed 23539594Robbins PF, Lu YC, El-Gamil M, Li YF, Gross C, Gartner J, Lin JC, Teer JK, Cliften P, Tycksen E, Samuels Y, Rosenberg SA. Mining exomic sequencing data to identify mutated antigens recognized by adoptively transferred tumor-reactive T cells. Nat Med. 2013 Jun;19(6):747-52. doi: 10.1038/nm.3161. Epub 2013 May 5.
PubMed 23644516Levin N, Kim SP, Marquardt CA, Vale NR, Yu Z, Sindiri S, Gartner JJ, Parkhurst M, Krishna S, Lowery FJ, Zacharakis N, Levy L, Prickett TD, Benzine T, Ray S, Masi RV, Gasmi B, Li Y, Islam R, Bera A, Goff SL, Robbins PF, Rosenberg SA. Neoantigen-specific stimulation of tumor-infiltrating lymphocytes enables effective TCR isolation and expansion while preserving stem-like memory phenotypes. J Immunother Cancer. 2024 May 30;12(5):e008645. doi: 10.1136/jitc-2023-008645.
PubMed 38816232White BS, Sindiri S, Hill V, Gasmi B, Nah S, Gartner JJ, Prickett TD, Li Y, Gurusamy D, Robbins P, Rosenberg SA, Leko V. Specific recognition of an FGFR2 fusion by tumor infiltrating lymphocytes from a patient with metastatic cholangiocarcinoma. J Immunother Cancer. 2023 Apr;11(4):e006303. doi: 10.1136/jitc-2022-006303.
PubMed 37045473Zacharakis N, Huq LM, Seitter SJ, Kim SP, Gartner JJ, Sindiri S, Hill VK, Li YF, Paria BC, Ray S, Gasmi B, Lee CC, Prickett TD, Parkhurst MR, Robbins PF, Langhan MM, Shelton TE, Parikh AY, Levi ST, Hernandez JM, Hoang CD, Sherry RM, Yang JC, Feldman SA, Goff SL, Rosenberg SA. Breast Cancers Are Immunogenic: Immunologic Analyses and a Phase II Pilot Clinical Trial Using Mutation-Reactive Autologous Lymphocytes. J Clin Oncol. 2022 Jun 1;40(16):1741-1754. doi: 10.1200/JCO.21.02170. Epub 2022 Feb 1.
PubMed 35104158
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Harvest and Preparation for Surgery Branch Treatment Protocols
- ClinicalTrials.gov ID
- NCT00068003
- Acronym / sponsor ID
- 030277
- Conditions
- Melanoma, Gastrointestinal Cancer, Metastatic Cancer, Breast Cancer, Non-Small Cell Lung Cancer
- Keywords
- Adoptive Cell Therapy, Screening, Cell Harvest, Blood, Tumor Tissue, Natural History
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 8 Sep 2003 (actual)
- First posted
- 4 Sep 2003 (estimated)
- 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.
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.
...
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1/Cancer Patients | – | Drug: Anti-CD19 CAR PBLPatients with a current diagnosis of cancer |
| 2/Healthy Volunteers | – | –Healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (13 listed)
- Patients must have a form of cancer currently being studied in the NCI-SB.
- Patient is able to understand and willing to sign a written informed consent document.
- Age greater than or equal to 18 years.
- Clinical performance status of ECOG 0 or 1.
- Serology
Key exclusion criteria (20 listed)
- Active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system.
- Patients who cannot give proper informed consent to the experimental therapy due to an active psychiatric disorder or inability to understand the nature of the proposed therapy and attendant risk.
- Women of child-bearing potential who are pregnant because of the potentially dangerous effects of some of the procedures (e.g., tumor biopsy or surgery for tumor resection) on the fetus.
- Has had babesiosis.
- Is at risk or has Creutzfeldt-Jakob 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 |
|---|---|---|
| Anti-CD19 CAR PBL | Drug | 1/Cancer Patients |
Primary outcome
Generating anti-tumor patient lymphocytes ex vivo
Time frame: Approximately 20 years
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
Time frame: Approximately 20 years
Conduct genomic, proteomic, and immunologic research studies on samples collected from patients with a current diagnosis of cancer.
To obtain autologous blood, stem cells, and/or tumor tissue from patients currently with cancer
Time frame: Approximately 20 years
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.
2 secondary outcomes
Repository of specimens and associated data
Time frame: Approximately 20 years
Long-term storage of data and biospecimens
Time frame: Approximately 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 12242449Dudley ME, Wunderlich JR, Robbins PF, Yang JC, Hwu P, Schwartzentruber DJ, Topalian SL, Sherry R, Restifo NP, Hubicki AM, Robinson MR, Raffeld M, Duray P, Seipp CA, Rogers-Freezer L, Morton KE, Mavroukakis SA, White DE, Rosenberg SA. Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes. Science. 2002 Oct 25;298(5594):850-4. doi: 10.1126/science.1076514. Epub 2002 Sep 19.
- Background: PubMed 23539594Vogelstein B, Papadopoulos N, Velculescu VE, Zhou S, Diaz LA Jr, Kinzler KW. Cancer genome landscapes. Science. 2013 Mar 29;339(6127):1546-58. doi: 10.1126/science.1235122.
- Background: PubMed 23644516Robbins PF, Lu YC, El-Gamil M, Li YF, Gross C, Gartner J, Lin JC, Teer JK, Cliften P, Tycksen E, Samuels Y, Rosenberg SA. Mining exomic sequencing data to identify mutated antigens recognized by adoptively transferred tumor-reactive T cells. Nat Med. 2013 Jun;19(6):747-52. doi: 10.1038/nm.3161. Epub 2013 May 5.
- Derived from this study: PubMed 38816232Levin N, Kim SP, Marquardt CA, Vale NR, Yu Z, Sindiri S, Gartner JJ, Parkhurst M, Krishna S, Lowery FJ, Zacharakis N, Levy L, Prickett TD, Benzine T, Ray S, Masi RV, Gasmi B, Li Y, Islam R, Bera A, Goff SL, Robbins PF, Rosenberg SA. Neoantigen-specific stimulation of tumor-infiltrating lymphocytes enables effective TCR isolation and expansion while preserving stem-like memory phenotypes. J Immunother Cancer. 2024 May 30;12(5):e008645. doi: 10.1136/jitc-2023-008645.
- Derived from this study: PubMed 37045473White BS, Sindiri S, Hill V, Gasmi B, Nah S, Gartner JJ, Prickett TD, Li Y, Gurusamy D, Robbins P, Rosenberg SA, Leko V. Specific recognition of an FGFR2 fusion by tumor infiltrating lymphocytes from a patient with metastatic cholangiocarcinoma. J Immunother Cancer. 2023 Apr;11(4):e006303. doi: 10.1136/jitc-2022-006303.
- Derived from this study: PubMed 35104158Zacharakis N, Huq LM, Seitter SJ, Kim SP, Gartner JJ, Sindiri S, Hill VK, Li YF, Paria BC, Ray S, Gasmi B, Lee CC, Prickett TD, Parkhurst MR, Robbins PF, Langhan MM, Shelton TE, Parikh AY, Levi ST, Hernandez JM, Hoang CD, Sherry RM, Yang JC, Feldman SA, Goff SL, Rosenberg SA. Breast Cancers Are Immunogenic: Immunologic Analyses and a Phase II Pilot Clinical Trial Using Mutation-Reactive Autologous Lymphocytes. J Clin Oncol. 2022 Jun 1;40(16):1741-1754. doi: 10.1200/JCO.21.02170. Epub 2022 Feb 1.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for 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
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
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.
Steven A Rosenberg, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Gastrointestinal Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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 13 inclusion and 20 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: enrolling by invitation, as of the sponsor's last update on 5 Nov 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Generating anti-tumor patient lymphocytes ex vivo (time frame: Approximately 20 years). The study lists 3 primary outcomes in all. 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 NCT00068003, which also lists 6 linked publications.
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 5 Nov 2026.