Kaposi SarcomaPhase 2NCT07308886
Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-Response (REGIMENKS HIV)
A Phase 2 study testing CYT107 in people with Kaposi Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Kaposi sarcoma (KS) is a cancer that causes abnormal tissue to grow in the skin, lymph nodes, and other organs. KS is caused by a virus known as Kaposi sarcoma herpesvirus. People infected with human immunodeficiency virus (HIV) account for 80% of KS cases in the United States. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kaposi Sarcoma
- What is being tested?
- CYT107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to 31 Jan 2037
- Phase
- Phase 2
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed KS by NCI Laboratory of Pathology (LP), with or without any prior systemic KS treatment
- Participants with HIV infection
- Age >= 18 years
- All participants should have at least five (5) measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.
- Participants with stage T1 KS with visceral involvement must:
- have any/all associated tumor associated symptoms <= Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v.6.0 criteria and/or,
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- require no immediate intervention (e.g., mild oozing of oral KS is allowed).
- Participants did not receive prior systemic therapy for KS or received prior systemic therapy and currently are either plateau in response, relapsed disease, progressive disease (PD), or inadequate response to treatment. Note: Previous local therapy or radiation is not considered systemic therapy.
- Participants must:
- have been on effective ART therapy for at least 2 months prior to the study drug initiation and
- have HIV VL <= 100 copies/mL and
- have persistent KS, affecting quality of life due to either T1 or T0 disease with inadequate disease regression on ART alone.
- ECOG PS <=3
- Adequate organ and marrow function as defined below:
- absolute neutrophil count (ANC) >= 500/mcL
- platelets >= 50,000/mcL
- hemoglobin (hgb) >= 8g/dL
- total bilirubin <= 1.5 institutional upper limit of normal (iULN) or <3 x iULN for Gilbert s syndrome or HIV protease inhibitors
- AST <= 2.5 x iULN
- ALT <= 2.5 x iULN
- CD4 T-cell count <= 350/mcL
- Participants must be willing to co-enroll to protocol 17C0174 "Molecular Characterization of Viral-associated Tumors, Tumors occurring in the Setting of HIV or other Immune Disorders and Castleman Disease"
- Participants with chronic hepatitis B virus (HBV) infection are eligible if they are on suppressive antiviral therapy.
- Participants with a hepatitis C virus (HCV) infection must have an undetectable HCV VL due to prior treatment or natural resolution.
- Women of child-bearing potential (WOCBP) and men able to father a child must agree to use an effective method of contraception (hormonal, barrier, surgical sterilization, abstinence) at the study entry, for the duration of study therapy, and for up to 4 months
- after discontinuation of study drug.
- Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after the last dose of the study drug.
- Participants must be able to understand and willing to sign a written informed consent document.
Who cannot join
- -Participants who have not recovered from immune-related AEs due to prior therapy (i.e., have residual toxicities > Grade 1 per CTCAE v.6.0).
- Note: Participants with hypothyroidism managed by supplemental levothyroxine are eligible.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to Chinese Hamster Ovary (CHO) cell products, chimeric or humanized antibodies or fusion proteins.
- Participants must not have received chemotherapy, radiotherapy, or other KS directed therapy other than ART for HIV within 2 weeks before the initiation of study drug.
- Participants must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) or systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or IL-2, pomalidomide, or immune checkpoint inhibitors) within 2 weeks before initiation of study treatment.
- Note: Participants who have received acute, low dose of systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled. The use of inhaled corticosteroids, and mineralocorticoids (e.g., fludrocortisone) for participants with orthostatic hypotension or adrenocortical insufficiency is allowed.
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- History or risk of autoimmune disease, except for:
- the presence of laboratory evidence of autoimmune disease (e.g., history of positive antinuclear antibody [ANA] titer or lupus anticoagulant) without associated symptoms,
- clinical evidence of vitiligo or other forms of depigmenting illness; and/or,
- mild autoimmunity not impacting the function of major organs (e.g., limited psoriasis).
- History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (e.g., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest x-ray.
- Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- History of allogeneic stem cell transplant and all other organ transplant.
- Another prior or concurrent malignancy requiring active therapy
- Active tuberculosis
- Positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test at screening.
- Participants must not have received prohibited therapies within 4 weeks before initiation of study treatment
- Severe uncontrolled intercurrent illness that would limit compliance with study requirements, as evaluated by history, physical exam, and chemistry panel.
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, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937, ncimo_referrals@mail.nih.gov
About this study
Official title: Phase II Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-response (REGIMEN-KS HIV)
Background:
Kaposi sarcoma (KS) is a cancer that causes abnormal tissue to grow in the skin, lymph nodes, and other organs. KS is caused by a virus known as Kaposi sarcoma herpesvirus. People infected with human immunodeficiency virus (HIV) account for 80% of KS cases in the United States. Having HIV can weaken the immune system and this can lead to KS. Weaker immune systems may be measured by low T cells (a type of immune cell). CYT107 is a human protein, made in a laboratory, that may help boost immunity, specifically by increasing T cells, in people with HIV-associated KS.
Read more
Objective:
To see if CYT107 can shrink KS tumors.
Eligibility:
People aged 18 years and older with HIV-associated KS.
Design:
Participants will be screened. They will have a physical exam with blood tests. Their skin lesions will be measured. They will have an x-ray of their lungs. Their ability to perform everyday tasks will be reviewed. A sample of lesion tissue (biopsy) may be collected from the skin.
CYT107 is injected into the muscle of the arm, buttocks, or lower thigh once a week for up to 4 weeks. Participants will receive the shots at the clinic. Blood and other tests will be repeated at each visit. KS lesions will be measured and photographed on the 1st and 4th visits.
Participants who improved after the first 4 weeks may have another 4-week treatment within a year.
Follow-up visits will continue for 3 years.
Read the detailed description
Background:
- Kaposi sarcoma (KS) is an angioproliferative tumor associated with KS-associated herpes virus (KSHV), also known as human herpesvirus 8 or (HHV-8) infection.
- Human immunodeficiency virus (HIV) infection-related KS accounts for greater than 80% of KS in the United States.
- Survival rates from HIV-related KS are poorer than classic KS, despite improving substantially with the introduction of antiretroviral therapy (ART).
- KS oncogenesis is associated with loss of T-cell mediated control of KSHV, the viral cause of KS.
- While treatment of persons with HIV (PWH) with ART can improve T-cell counts and immunity, their T-cell counts often do not return to normal and they are often left with residual immunodeficiency.
- There are a group of patients who have well controlled HIV but continue to have low CD4 T-cell counts (<=350 cells/mcL) who are termed immune non-responders . This group possess a high rate of KS persistence, and chemotherapy can often contribute to lymphopenia.
- The cytokine interleukin-7 (IL-7) plays an important role in T-cell development and proliferation and regulates T-cell homeostasis throughout life.
- IL-7 administration is very potent at producing new T cells such as na(SqrRoot) ve T cells and recent thymic emigrants.
- Administration of short acting recombinant human IL-7 was well-tolerated and has resulted in a dose-dependent increase in peripheral T cells and broadening of T-cell receptor (TCR) diversity.
Objective:
-To assess the overall response rate (ORR) of CYT107 defined as the best response (complete response [CR], clinical complete response [CRR], partial response [PR]) within 24 weeks in the first course of treatment, using the modified AIDS Clinical Trial Group
(ACTG) KS response criteria in immune non-response participants with HIV-associated KS who had prior systemic KS therapy or who are KS therapy naive
Eligibility:
- Age >=18 years
- Histologically confirmed diagnosis of KS in people with HIV.
- All participants should have at least five (5) measurable cutaneous KS lesions.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=3
- CD4 T cell count <=350 cells/mcL
Design:
- This is an open label, nonrandomized Phase II study assessing the safety and activity of CYT107 in participants with HIV-associated KS.
- Participants will be enrolled in two cohorts based on prior exposure to KS therapy.
- A safety run-in will be conducted for the first 12 participants with no more than three participants treated simultaneously.
- Participants will receive CYT107 at 20 mcg/kg by intramuscular (IM) injections every week for up to 4 weeks/4 doses.
- Participants who have an increase in CD4 T-cell count following administration of CYT107 and evidence of KS response per ACTG criteria but subsequently experience a decrease in CD4 T-cell count (>=100 cells/mcL) with associated deterioration in KS, or have had prior systemic KS therapy and first course resulted in SD only, may be eligible to receive a second course of CYT107 administration (for up to 4 weeks/4 doses).
-Up to 29 evaluable participants will be enrolled.
- Conditions
- Kaposi Sarcoma
- Being tested
- CYT107
- Keywords
- human herpesvirus 8, KS-associated herpes virus, HIV, Interleukin-7, Lymphoproliferative Disorder
- Medical subject headings
- Sarcoma, Kaposi, Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT107Drug
CYT107 is administered by IM injections at 20 mcg/kg every week for up to 4 weeks/4 doses
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Treatment with CYT107 Receives: Drug: CYT107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit
Percentage of participants with the best overall response of CR, CRR, or PR to therapy.
Measured: Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (week 24)
Secondary outcomes (5)
Safety of CYT107
Adverse events (AEs) will be reported by type and grade of toxicity
Measured: Prior to each cycle, at EOT (week 8), and at safety visits (weeks 12 and 16)
Time of duration of response
The interval between initiating therapy and the time to disease progression in patients who achieve CR, PR, or SD.
Measured: Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (up to 3 years post-treatment)
Time of progression free survival
The interval between initiating therapy and the time to disease progression or death, whichever happens first
Measured: Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (up to 3 years post-treatment)
Proportion of participants requiring a second course of CYT107.
Percentage of participants who meet criteria and receive second course of treatment
Measured: ongoing
Clinical benefit of a second course of CYT107
Percentage of participants that received a second course with the best overall response of CR, CRR, or PR to therapy.
Measured: Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start8 Apr 2026
- Primary completion31 Jan 2036 (estimated)
- Study completion31 Jan 2037 (estimated)
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 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ramya M Ramaswami, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308886
- Sponsor's protocol ID
- 10002361
- Other IDs
- 002361-C
- Status last verified
- 21 Aug 2026
- First submitted
- 24 Dec 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) for the Treatment of Kaposi Sarcoma in Participants With HIV and Immune Non-response (REGIMEN-KS HIV)
- ClinicalTrials.gov ID
- NCT07308886
- Acronym / sponsor ID
- 10002361
- Conditions
- Kaposi Sarcoma
- Keywords
- human herpesvirus 8, KS-associated herpes virus, HIV, Interleukin-7, Lymphoproliferative Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 31 Jan 2036 (estimated)
- Study completion
- 31 Jan 2037 (estimated)
- First posted
- 30 Dec 2025 (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.
Background:
Kaposi sarcoma (KS) is a cancer that causes abnormal tissue to grow in the skin, lymph nodes, and other organs. KS is caused by a virus known as Kaposi sarcoma herpesvirus. People infected with human immunodeficiency virus (HIV) account for 80% of KS cases in the United States. Having HIV can weaken the immune system and this can lead to KS. Weaker immune systems may be measured by low T cells (a type of immune cell). CYT107 is a human protein, made in a laboratory, that may help boost immunity, specifically by increasing T cells, in people with HIV-associated KS.
Objective:
To see if CYT107 can shrink KS tumors.
Eligibility:
People aged 18 years and older with HIV-associated KS.
Design:
Participants will be screened. They will have a physical exam with blood tests. Their skin lesions will be measured. They will have an x-ray of their lungs. Their ability to perform everyday tasks will be reviewed. A sample of lesion tissue (biopsy) may be collected from the skin.
CYT107 is injected into the muscle of the arm, buttocks, or lower thigh once a week for up to 4 weeks. Participants will receive the shots at the clinic. Blood and other tests will be repeated at each visit. KS lesions will be measured and photographed on the 1st and 4th visits.
Participants who improved after the first 4 weeks may have another 4-week treatment within a year.
Follow-up visits will continue for 3 years.
Detailed description
Background:
- Kaposi sarcoma (KS) is an angioproliferative tumor associated with KS-associated herpes virus (KSHV), also known as human herpesvirus 8 or (HHV-8) infection.
- Human immunodeficiency virus (HIV) infection-related KS accounts for greater than 80% of KS in the United States.
- Survival rates from HIV-related KS are poorer than classic KS, despite improving substantially with the introduction of antiretroviral therapy (ART).
- KS oncogenesis is associated with loss of T-cell mediated control of KSHV, the viral cause of KS.
- While treatment of persons with HIV (PWH) with ART can improve T-cell counts and immunity, their T-cell counts often do not return to normal and they are often left with residual immunodeficiency.
- There are a group of patients who have well controlled HIV but continue to have low CD4 T-cell counts (<=350 cells/mcL) who are termed immune non-responders . This group possess a high rate of KS persistence, and chemotherapy can often contribute to lymphopenia.
- The cytokine interleukin-7 (IL-7) plays an important role in T-cell development and proliferation and regulates T-cell homeostasis throughout life.
- IL-7 administration is very potent at producing new T cells such as na(SqrRoot) ve T cells and recent thymic emigrants.
- Administration of short acting recombinant human IL-7 was well-tolerated and has resulted in a dose-dependent increase in peripheral T cells and broadening of T-cell receptor (TCR) diversity.
Objective:
-To assess the overall response rate (ORR) of CYT107 defined as the best response (complete response [CR], clinical complete response [CRR], partial response [PR]) within 24 weeks in the first course of treatment, using the modified AIDS Clinical Trial Group
(ACTG) KS response criteria in immune non-response participants with HIV-associated KS who had prior systemic KS therapy or who are KS therapy naive
Eligibility:
- Age >=18 years
- Histologically confirmed diagnosis of KS in people with HIV.
- All participants should have at least five (5) measurable cutaneous KS lesions.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=3
- CD4 T cell count <=350 cells/mcL
Design:
- This is an open label, nonrandomized Phase II study assessing the safety and activity of CYT107 in participants with HIV-associated KS.
- Participants will be enrolled in two cohorts based on prior exposure to KS therapy.
- A safety run-in will be conducted for the first 12 participants with no more than three participants treated simultaneously.
- Participants will receive CYT107 at 20 mcg/kg by intramuscular (IM) injections every week for up to 4 weeks/4 doses.
- Participants who have an increase in CD4 T-cell count following administration of CYT107 and evidence of KS response per ACTG criteria but subsequently experience a decrease in CD4 T-cell count (>=100 cells/mcL) with associated deterioration in KS, or have had prior systemic KS therapy and first course resulted in SD only, may be eligible to receive a second course of CYT107 administration (for up to 4 weeks/4 doses).
-Up to 29 evaluable participants will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: CYT107Treatment with CYT107 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Histologically confirmed KS by NCI Laboratory of Pathology (LP), with or without any prior systemic KS treatment
- Participants with HIV infection
- Age >= 18 years
- All participants should have at least five (5) measurable cutaneous KS lesions with no previous local radiation, surgical or intralesional cytotoxic therapy that would prevent response assessment for that lesion.
- Participants with stage T1 KS with visceral involvement must:
Key exclusion criteria (18 listed)
- -Participants who have not recovered from immune-related AEs due to prior therapy (i.e., have residual toxicities > Grade 1 per CTCAE v.6.0).
- Note: Participants with hypothyroidism managed by supplemental levothyroxine are eligible.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to Chinese Hamster Ovary (CHO) cell products, chimeric or humanized antibodies or fusion proteins.
- Participants must not have received chemotherapy, radiotherapy, or other KS directed therapy other than ART for HIV within 2 weeks before the initiation of study drug.
- Participants must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) or systemic immunostimulatory agents (including, but not limited to, interferon [IFN]-alpha or IL-2, pomalidomide, or immune checkpoint inhibitors) within 2 weeks before initiation of study treatment.
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 |
|---|---|---|
| CYT107CYT107 is administered by IM injections at 20 mcg/kg every week for up to 4 weeks/4 doses | Drug | Arm 1 |
Primary outcome
Clinical benefit
Time frame: Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (week 24)
Percentage of participants with the best overall response of CR, CRR, or PR to therapy.
5 secondary outcomes
Safety of CYT107
Time frame: Prior to each cycle, at EOT (week 8), and at safety visits (weeks 12 and 16)
Time of duration of response
Time frame: Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (up to 3 years post-treatment)
Time of progression free survival
Time frame: Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (up to 3 years post-treatment)
Proportion of participants requiring a second course of CYT107.
Time frame: ongoing
Clinical benefit of a second course of CYT107
Time frame: Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (week 24)
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 25 Aug 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review and/or will involve genomic data sharing.
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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.
Ramya M Ramaswami, 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?
A Phase 2 study testing CYT107 in people with Kaposi Sarcoma, 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 28 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 25 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Contact NCI Referral Office ((888) 624-1937, ncimo_referrals@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical benefit (time frame: Baseline/prior to treatment (week 1/cycle 1), at cycle 4 (week 4), at EOT (week 8), at safety visits (weeks 12 and 16), and in follow-up (week 24)). 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 Aug 2026.