Kaposi SarcomaEarly Phase 1NCT03316274
Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma
A Early Phase 1 study testing Nivolumab in people with Kaposi Sarcoma and HIV/AIDS, run by University of California, San Francisco at 1 site in United States.
Trial summary
Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kaposi Sarcoma, HIV/AIDS, Immunosuppression
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 30 Jun 2021
- Phase
- Early Phase 1
- 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
- For screening: Participants must have histologically confirmed KS with active cutaneous disease and have less than 25 lesions. For enrollment: Participants must have histologically confirmed KS in the research skin biopsy performed during the screening visit.
- Participants must have measurable cutaneous KS disease, defined as 1 or more marker lesion that is bi-dimensionally measurable, and >=0.5cm in shortest dimension. These measurable lesions must not have received previous local radiation, surgical, or intralesional cytotoxic therapy that would prevent response assessment. Note: Participants may eligible even if some KS lesions that have previously been treated with local therapy, as long as other untreated KS lesions are measurable as defined in the protocol.
- For the initial safety cohort (cohort A), participants have to be treatment-experienced, i.e. at least one of the KS skin lesions has been persisted despite having been treated with:
- systemic chemotherapy; OR
- 1 or more topical therapy, local radiation, surgery, or intra-lesional cytotoxic therapy.
- For the expansion cohort (cohort B), participants can be either treatment-experienced or treatment-naïve.
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- For the extension cohort (cohort B-plus), participants are from the expansion cohort above (cohort B) who have achieved partial response (PR) or complete response (CR) in their injected KS lesion at week 26 or later.
- Age >= 18 years.
- If human immunodeficiency virus (HIV)-infected, participants must have:
- HIV-1 infection, documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or ELISA, test kit, and confirmed by Western blot or other approved test). Alternatively, this documentation may include a record demonstrating that another physician has documented the participant's HIV status based on either: 1) approved diagnostic tests, or 2) the referring physician's written record that HIV infection was documented, with supporting information on the participant's relevant medical history and/or current management of HIV infection
- CD4 >= 350 cells/mm3
- HIV-1 viral load below the limit of detection by commercial assays (<75 copies/mL).
- Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management. Participants should be documented to be on an effective combination anti-retroviral (ART) regimen, generally a 3-drug regimen based on Department of Health and Human Services (DHHS) treatment guidelines by a licensed health care provider. Participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 12 weeks following enrollment.
- If HIV-uninfected, participants must have documentation of a negative HIV result by any federally approved, licensed HIV test within the last 12 months.
- Adequate organ function defined as follows:
- Leukocytes > 3,000/microliter (mcL).
- Absolute neutrophil count > 1,000/mcL.
- Hemoglobin > 10 g/dL.
- Platelets > 100,000/mcL.
- Total bilirubin within normal institutional limits.
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) < 2.5 X institutional upper limit of normal (ULN)
- Alanine aminotransferase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) < 2.5 X institutional ULN
- Creatinine < 1.5 X institutional ULN
- Participants must be purified protein derivative (PPD) negative. Alternatively, the QuantiFERON-TB Gold In-Tube (QFT-GIT) assay (Cellestis Limited, Carnegie, Australia) can be used. An individual is considered positive for M. tuberculosis (TB) infection if the Interferon (IFN)-gamma response to TB antigens is above the test cut-off (after subtracting the background IFN-gamma response in the negative control). The result must be obtained within 12 months prior to enrollment. PPD positive (or QuantiFERON assay positive) participants are permitted if prophylaxis has been completed prior to enrollment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of <=1 (Karnofsky >= 70%).
- The effects of nivolumab on the developing fetus are unknown. Therefore, only the following patients should be enrolled:
- Woman of child-bearing potential (WOCBP), defined as a sexually mature woman who has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries)) or, has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months} must have negative serum pregnancy test within 7 days before starting study treatment in WOCBP and willingness to adhere to acceptable forms or birth control (a physician-approved contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner).
- WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 6 months after the last dose.
- Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study (including the time after last dose previously mentioned), she (or the participating partner) should inform the treating physician immediately.
- Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product.
Who cannot join
- Prior systemic KS-directed treatments or investigational modalities <= 5 half-lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy to grade 1 or less.
- Presence of any visceral KS (including KS-associated lymphedema) requiring systemic chemotherapy. This includes, but not limited to, any symptomatic visceral KS or asymptomatic pulmonary KS.
- Hypersensitivity to nivolumab or any of its excipients.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Opportunistic infection within the last 3 months.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
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- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. This does not apply to participants in the extension cohort (cohort B-plus).
- Active systemic immunosuppressive therapy.
- The use of prednisone or equivalent 10mg or greater a day that cannot be discontinued with more than 7 consecutive days of steroids within the prior 2 weeks.
- Prior organ allograft or allogeneic transplantation, if the transplanted tissue is still in place.
- Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure.
- Major surgery ≤ 2 weeks prior to starting a study drug or who have not recovered from side effects of such therapy.
- Any significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Any condition that confounds the ability to interpret data from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Phase 1 Study to Evaluate the Safety, Feasibility and Immunologic Correlatives of Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma
Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Evolution of immunosuppressive mechanisms presumably plays a permissive role in the development, progression and recurrence of these virus-associated cancers and pre-cancers. Currently, available treatment options for these lesions are imperfect and there is no clear treatment for patients with limited cutaneous Kaposi sarcoma (KS). Radiation and injection of vinblastine both have side effects that may not be acceptable. Nivolumab has been used to treat more extensive KS when given intravenously. To the best of the investigator's knowledge, this is the first study to evaluate the safety of intra-lesional injections of nivolumab in patients with KS.
Read the detailed description
This is a single-center, phase I safety/expansion trial of nivolumab in HIV-infected (with stable, treated HIV on cART) and HIV-uninfected patients with limited cutaneous KS.
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of four intra-lesional injections of nivolumab given every two weeks to treat KS. They will be assessed by NCI Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v. 5).
SECONDARY OBJECTIVES:
- To determine the changes in cytotoxic T cells and regulatory T cells in the lesions as determined by immunohistochemistry and flow cytometry.
- To determine the changes in cytotoxic T cells and regulatory T cells in the peripheral blood as determined by flow cytometry.
- To determine the changes in PD-1/PD-L1 expression as determined by immunohistochemistry in lesions.
OUTLINE:
Participants with treatment-experienced KS will be enrolled into Cohort A (initial safety cohort). If there are no grade 3 or higher adverse events, enrollment into the expansion cohort (Cohort) B will be available to participants with either treatment-experienced or treatment-naïve KS, including those previously enrolled in the safety cohort.
Patients will receive one intra-lesional injection of nivolumab into one cutaneous KS lesion every 2 weeks for up to a total of 4 doses until completed or intolerable toxicity, request to withdraw, or withdrawal per the Principal Investigator. Participants will be followed for an additional 5 months after completing the 4 treatment doses.
- Conditions
- Kaposi Sarcoma, HIV/AIDS, Immunosuppression
- Being tested
- Nivolumab
- Medical subject headings
- Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Nivolumab Injection, Opdivo
Given via intralesional injection
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab (Cohort A-Safety) | Experimental | Participants will receive a 10mg (or 1 mL) injection into a single KS lesion in the skin, every 2 weeks for 4 doses. Receives: Drug: Nivolumab |
| Nivolumab (Cohort B-Expansion) | Experimental | Participants from Cohort A with at least 1 lesion that is left untreated and additional participants receive injections in into up to 2 KS lesions in the skin, every 2 weeks for 4 doses. The injected volume will not exceed 10 mg (or 1 mL) each time. Lesions will be evaluated at week 26, and participants with lesion improvement may enroll in Cohort B-PLUS to receive additional injections. Receives: Drug: Nivolumab |
| Nivolumab (Cohort B-PLUS) | Experimental | Participants in Cohort B whose injected lesions achieved partial response or complete response by week 26 and who did not experience any serious adverse events, are permitted to receive additional injections up to 4 residual KS lesions (total volume 10 mg in 1 mL) every 2 weeks for up to 4 additional doses. Lesions will be assessed again after 26 weeks. Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number participants with Dose Limiting Toxicities (DLT) (Cohort A)
The number of participants with DLTs will defined as treatment-related, grade 3-5 adverse events assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 6 months
Maximum Tolerated Dose (MTD) (Cohort A)
The MTD is defined as the dose at which no more than 1/6 patients experience a DLT
Measured: 6 months
Secondary outcomes (9)
Median percent change in absolute CD3 cells (CD3+) / CD4+ cells
Treatment induced, tumor infiltrating immune cells will be evaluated in pre-treatment and post-treatment tissue via immunohistochemistry (IHC).
Measured: 6 months
Median percent change in cytotoxic T cells with CD8 surface protein (CD8+) T cells /Granzyme+ T cytotoxic T cells
Treatment induced, tumor infiltrating immune cells will be evaluated in pre-treatment and post-treatment tissue via immunohistochemistry (IHC).
Measured: 6 months
Median percent change in CD56+ natural killer (NK) cells
Treatment induced, tumor infiltrating immune cells will be evaluated in pre-treatment and post-treatment tissue via immunohistochemistry (IHC).
Measured: 6 months
Median percent change in CD4+FOXP3-effector T cells
Treatment induced, tumor infiltrating immune cells will be evaluated in pre-treatment and post-treatment tissue via immunohistochemistry (IHC).
Measured: 6 months
Median percent change in CD4+FOXP3+regulatory T cells
Treatment induced, tumor infiltrating immune cells will be evaluated in pre-treatment and post-treatment tissue via immunohistochemistry (IHC).
Measured: 6 months
Changes in Circulating plasma cytokines
Circulating plasma cytokines will be evaluated in pre-treatment and post-treatment
Measured: 6 months
Changes in frequency of circulating activated T cells in the peripheral blood
Frequency of circulating activated T cells in the peripheral blood induced by intra-lesional nivolumab therapy will be assessed via flow cytometry
Measured: 6 months
Median change in number of circulating activated T cells in the peripheral blood
Changes in number of circulating activated T cells in the peripheral blood induced by intra-lesional nivolumab therapy will be assessed via flow cytometry
Measured: 6 months
Changes in PD-1 expression as determined by immunohistochemistry in lesions
Changes in PD-L1 expression induced by intra-lesional nivolumab therapy will be assessed via IHC, using commercially available PD-1 antibody.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start7 May 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kaposi SarcomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chia-ching Wang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316274
- Sponsor's protocol ID
- 17872
- Other IDs
- NCI-2018-02529, P30CA082103
- Status last verified
- Jun 2024
- First submitted
- 29 Sep 2017
- Last updated
- 25 Jun 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Safety, Feasibility and Immunologic Correlatives of Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma
- ClinicalTrials.gov ID
- NCT03316274
- Acronym / sponsor ID
- 17872
- Conditions
- Kaposi Sarcoma, HIV/AIDS, Immunosuppression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, National Cancer Institute (NCI)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Oct 2017 (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.
Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Evolution of immunosuppressive mechanisms presumably plays a permissive role in the development, progression and recurrence of these virus-associated cancers and pre-cancers. Currently, available treatment options for these lesions are imperfect and there is no clear treatment for patients with limited cutaneous Kaposi sarcoma (KS). Radiation and injection of vinblastine both have side effects that may not be acceptable. Nivolumab has been used to treat more extensive KS when given intravenously. To the best of the investigator's knowledge, this is the first study to evaluate the safety of intra-lesional injections of nivolumab in patients with KS.
Detailed description
This is a single-center, phase I safety/expansion trial of nivolumab in HIV-infected (with stable, treated HIV on cART) and HIV-uninfected patients with limited cutaneous KS.
PRIMARY OBJECTIVES:
- To determine the safety and tolerability of four intra-lesional injections of nivolumab given every two weeks to treat KS. They will be assessed by NCI Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v. 5).
SECONDARY OBJECTIVES:
- To determine the changes in cytotoxic T cells and regulatory T cells in the lesions as determined by immunohistochemistry and flow cytometry.
- To determine the changes in cytotoxic T cells and regulatory T cells in the peripheral blood as determined by flow cytometry.
- To determine the changes in PD-1/PD-L1 expression as determined by immunohistochemistry in lesions.
OUTLINE:
Participants with treatment-experienced KS will be enrolled into Cohort A (initial safety cohort). If there are no grade 3 or higher adverse events, enrollment into the expansion cohort (Cohort) B will be available to participants with either treatment-experienced or treatment-naïve KS, including those previously enrolled in the safety cohort.
Patients will receive one intra-lesional injection of nivolumab into one cutaneous KS lesion every 2 weeks for up to a total of 4 doses until completed or intolerable toxicity, request to withdraw, or withdrawal per the Principal Investigator. Participants will be followed for an additional 5 months after completing the 4 treatment doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nivolumab (Cohort A-Safety) | Experimental | Drug: NivolumabParticipants will receive a 10mg (or 1 mL) injection into a single KS lesion in the skin, every 2 weeks for 4 doses. |
| Nivolumab (Cohort B-Expansion) | Experimental | Drug: NivolumabParticipants from Cohort A with at least 1 lesion that is left untreated and additional participants receive injections in into up to 2 KS lesions in the skin, every 2 weeks for 4 doses. The injected volume will not exceed 10 mg (or 1 mL) each time. Lesions will be evaluated at week 26, and participants with lesion improvement may enroll in Cohort B-PLUS to receive additional injections. |
| Nivolumab (Cohort B-PLUS) | Experimental | Drug: NivolumabParticipants in Cohort B whose injected lesions achieved partial response or complete response by week 26 and who did not experience any serious adverse events, are permitted to receive additional injections up to 4 residual KS lesions (total volume 10 mg in 1 mL) every 2 weeks for up to 4 additional doses. Lesions will be assessed again after 26 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- For screening: Participants must have histologically confirmed KS with active cutaneous disease and have less than 25 lesions. For enrollment: Participants must have histologically confirmed KS in the research skin biopsy performed during the screening visit.
- Participants must have measurable cutaneous KS disease, defined as 1 or more marker lesion that is bi-dimensionally measurable, and >=0.5cm in shortest dimension. These measurable lesions must not have received previous local radiation, surgical, or intralesional cytotoxic therapy that would prevent response assessment. Note: Participants may eligible even if some KS lesions that have previously been treated with local therapy, as long as other untreated KS lesions are measurable as defined in the protocol.
- For the initial safety cohort (cohort A), participants have to be treatment-experienced, i.e. at least one of the KS skin lesions has been persisted despite having been treated with:
- For the expansion cohort (cohort B), participants can be either treatment-experienced or treatment-naïve.
- For the extension cohort (cohort B-plus), participants are from the expansion cohort above (cohort B) who have achieved partial response (PR) or complete response (CR) in their injected KS lesion at week 26 or later.
Key exclusion criteria (14 listed)
- Prior systemic KS-directed treatments or investigational modalities <= 5 half-lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy to grade 1 or less.
- Presence of any visceral KS (including KS-associated lymphedema) requiring systemic chemotherapy. This includes, but not limited to, any symptomatic visceral KS or asymptomatic pulmonary KS.
- Hypersensitivity to nivolumab or any of its excipients.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Opportunistic infection within the last 3 months.
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 |
|---|---|---|
| NivolumabAlso: Nivolumab Injection, OpdivoGiven via intralesional injection | Drug | Nivolumab (Cohort A-Safety), Nivolumab (Cohort B-Expansion), Nivolumab (Cohort B-PLUS) |
Primary outcome
Number participants with Dose Limiting Toxicities (DLT) (Cohort A)
Time frame: 6 months
The number of participants with DLTs will defined as treatment-related, grade 3-5 adverse events assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Maximum Tolerated Dose (MTD) (Cohort A)
Time frame: 6 months
The MTD is defined as the dose at which no more than 1/6 patients experience a DLT
9 secondary outcomes
Median percent change in absolute CD3 cells (CD3+) / CD4+ cells
Time frame: 6 months
Median percent change in cytotoxic T cells with CD8 surface protein (CD8+) T cells /Granzyme+ T cytotoxic T cells
Time frame: 6 months
Median percent change in CD56+ natural killer (NK) cells
Time frame: 6 months
Median percent change in CD4+FOXP3-effector T cells
Time frame: 6 months
Median percent change in CD4+FOXP3+regulatory T cells
Time frame: 6 months
Changes in Circulating plasma cytokines
Time frame: 6 months
Changes in frequency of circulating activated T cells in the peripheral blood
Time frame: 6 months
Median change in number of circulating activated T cells in the peripheral blood
Time frame: 6 months
Changes in PD-1 expression as determined by immunohistochemistry in lesions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 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.
Chia-ching Wang, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nivolumab in people with Kaposi Sarcoma and HIV/AIDS, run by University of California, San Francisco 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 30 inclusion and 14 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: finished, as of the sponsor's last update on 25 Jun 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number participants with Dose Limiting Toxicities (DLT) (Cohort A) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 25 Jun 2024.