Malignant Melanoma Stage IVPhase 2NCT03166397
Adoptive Cell Therapy Following a Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients
A Phase 2 study testing Fludarabine, Cyclophosphamide and TIL in people with Malignant Melanoma Stage IV, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in combination with lymphodepletion and high-dose interleukin 2 (IL-2) has demonstrated reproducible objective response rates of approximately 50 percent in patients with highly advanced, refractory metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Melanoma Stage IV
- What is being tested?
- Fludarabine, Cyclophosphamide and TIL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Jun 2017to 1 Jun 2026
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Measurable metastatic Melanoma with at least one lesion that is resectable for TIL generation.
- Refractory to standard treatment
- Patients with one or more brain metastases less than 1 cm each, and any patients with 1 or 2 brain metastases greater than 1 cm must have been treated and stable for 6 weeks.
- Greater than or equal to 18 years of age.
- Willing to practice birth control from the start of chemotherapy until 120 days after release from the hospital.
- Clinical performance status of ECOG 0 or 1
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- Hematology:
- Absolute neutrophil count greater than 1000/mm3 without support of filgrastim Normal WBC (greater than 3000/mm3). Hemoglobin greater than 8.0 g/dL Platelet count greater than 100,000/mm3
- Serology:
- Seronegative for HIV antibody. Seronegative for Hepatitis B or Hepatitis C.
- Chemistry:
- Serum ALT/AST less than three times the upper limit of normal (ULN). Serum creatinine less than or equal to 1.6 mg/dL Total bilirubin no more than 1.5 times the ULN, except in patients with Gilbert Syndrome who must have a total bilirubin less than 3 mg/dL.
- Negative pregnancy test in women of child bearing potential because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
- More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients may have undergone minor surgical procedures with the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.
Who cannot join
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the non-myeloablative, lymphodepleting induction regimen on the fetus or infant.
- Systemic steroid therapy required.
- Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
- Opportunistic infections (the experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
- History of severe immediate hypersensitivity reaction to any of the agents used in this study , including history of an anaphylactic reaction to penicillin or gentamicin
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- History of coronary revascularization or ischemic symptoms
- Any patient known to have an LVEF less than or equal to 50 percent .
- Documented LVEF of less than or equal to 50 percent tested in patients with clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block
- Documented FEV1 and DLCO (relative to predicted) less than or equal to 60 percent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 5262100
Meital Bar, 972-3-5305201, meital.bar@sheba.health.gov.il
Jacob Schachter, MD
About this study
Official title: A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients
Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in combination with lymphodepletion and high-dose interleukin 2 (IL-2) has demonstrated reproducible objective response rates of approximately 50 percent in patients with highly advanced, refractory metastatic melanoma.
Recent developments in theTIL ACT procedure facilitate the use of a reduced-intensity, non-myeloablative, lympho-depleting preparative regimen which is expected to be both less toxic and equally efficient compared to previous regimens.
Read more
Recently patients recruited post Anti PD-1 therapy had inferior responses in comparison to the pre immune checkpoint inhibitors era. Therefore 2 new arms were added:
- TIL-ACT with combination of 2 doses of Nivolumab fixed dose 480mg, pre and post TIL.
- TIL-ACT with FMT given using colonoscopy once and 2 maintenance doses of 12 orally ingested capsules, concurrently with a single dose of Ipilimumab 1 mg/kg up to 100 mg.
Read the detailed description
The Sponsor is developing the ex-vivo expanded autologous TIL as the Investigational Product (IP). Yet, the administration of the TIL cellular product can only be accomplished in the context of an autologous, Adoptive Cell Therapy (ACT) procedure which is composed of the following steps:
- Reduced Intensity, non-myeloablative, lymphodepleting induction regimen using Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.
- Bolus high-dose (720,000 IU/kg) IL-2, which will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient.
- Early-stage follow-up until 30 days post-discharge
- Late-stage follow-up, such as CT scans, will be carried out four and twelve weeks after TIL administration, and then every 3 months thereafter for the first year after TIL therapy; for the second year and onwards, as clinically indicated.
Recently 2 new arms were, using the same protocol described above with the following additions:
Arm 2 - TIL-ACT + Anti PD-1 -the addition of 2 doses of Nivolumab fixed dose 480mg, pre and post TIL.
Arm 3 - TIL-ACT with FMT + Anti CTLA4 - the addition of FMT given using colonoscopy once and 2 maintenance doses of 12 orally ingested capsules, concurrently with a single dose of Ipilimumab 1 mg/kg up to 100 mg.
- Conditions
- Malignant Melanoma Stage IV
- Being tested
- Fludarabine, Cyclophosphamide, TIL, IL-2, Nivolumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.
CyclophosphamideDrug
Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.
TILBiological
TIL administration
IL-2Drug
Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient.
NivolumabDrug
Nivolumab 480 mg fixed dose
IpilimumabDrug
Ipilimumab 1 mg/kg up to 100 mg
FMT ProtocolDrug
FMT given both directly into the colon via colonoscopy and orally using capsules (12 capsules each time).
FMT will be taken from melanoma patients treated with Anti PD-1 who achieved a durable response of more than 12 months.
| Study group | Role | What they receive |
|---|---|---|
| ACT TIL | Experimental | 1. Reduced Intensity, non-myeloablative, lymphodepleting induction regimen using Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d..
2. Preparation and administration of TIL
3. Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: TIL; Drug: IL-2 |
| ACT TIL + Anti PD-1 | Experimental | 1. Single dose of Nivolumab 480 mg fixed dose
2. Reduced Intensity, non-myeloablative, lymphodepleting induction regimen using Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d..
3. Preparation and administration of TIL
4. Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient.
5. Second dose of Nivolumab 480 mg fixed dose (at least 4 weeks from the first dose) Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: TIL; Drug: IL-2; Drug: Nivolumab |
| ACT TIL FMT + Anti CTLA4 | Experimental | 1. FMT loading dose given via colonoscopy
2. FMT 12 oral capsules as maintenance - given 2 times
3. Single dose of Ipilimumab 1mg/kg up to 100 mg
4. Reduced Intensity, non-myeloablative, lymphodepleting induction regimen using Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d..
5. Preparation and administration of TIL
6. Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: TIL; Drug: IL-2; Drug: Ipilimumab; Drug: FMT Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor responses
Radiological follow up via CT to determine the sum of Complete Responders (CR) + Partial Responders (PR) + Stable Disease (SD) as assessed by RECIST 1.1
Measured: 3 years
Assess adverse events using NCI CTCAE v4.03 during treatment and follow-up
Adverse events will be assessed using NCI CTCAE v4.03 during treatment and follow-up
Measured: 3 years
Secondary outcomes (4)
Overall Survival (OS)
Overall survival is defined as the time from study entry until death from any cause
Measured: 3 years
Response Rate (RR)
Radiological follow up via CT to determine the sum of Complete Responders (CR) + Partial Responders (PR) as assessed by RECIST 1.1
Measured: 3 years
Progression-Free Survival (PFS)
Progression free survival according to RECIST 1.1
Measured: 3 years
Quality of Life (QoL)
Assessment of QoL using the EORTC QLQ-MEL38 instrument (specific for Melanoma)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start5 Jun 2017
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Melanoma Stage IVStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166397
- Sponsor's protocol ID
- SHEBA-16-3566-JS-CTIL
- Status last verified
- Jan 2023
- First submitted
- 21 May 2017
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be considered
Publications
Nissani A, Lev-Ari S, Meirson T, Jacoby E, Asher N, Ben-Betzalel G, Itzhaki O, Shapira-Frommer R, Schachter J, Markel G, Besser MJ. Comparison of non-myeloablative lymphodepleting preconditioning regimens in patients undergoing adoptive T cell therapy. J Immunother Cancer. 2021 May;9(5):e001743. doi: 10.1136/jitc-2020-001743.
PubMed 33990415
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients
- ClinicalTrials.gov ID
- NCT03166397
- Acronym / sponsor ID
- SHEBA-16-3566-JS-CTIL
- Conditions
- Malignant Melanoma Stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 May 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.
Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TILs) in combination with lymphodepletion and high-dose interleukin 2 (IL-2) has demonstrated reproducible objective response rates of approximately 50 percent in patients with highly advanced, refractory metastatic melanoma.
Recent developments in theTIL ACT procedure facilitate the use of a reduced-intensity, non-myeloablative, lympho-depleting preparative regimen which is expected to be both less toxic and equally efficient compared to previous regimens.
Recently patients recruited post Anti PD-1 therapy had inferior responses in comparison to the pre immune checkpoint inhibitors era. Therefore 2 new arms were added:
- TIL-ACT with combination of 2 doses of Nivolumab fixed dose 480mg, pre and post TIL.
- TIL-ACT with FMT given using colonoscopy once and 2 maintenance doses of 12 orally ingested capsules, concurrently with a single dose of Ipilimumab 1 mg/kg up to 100 mg.
Detailed description
The Sponsor is developing the ex-vivo expanded autologous TIL as the Investigational Product (IP). Yet, the administration of the TIL cellular product can only be accomplished in the context of an autologous, Adoptive Cell Therapy (ACT) procedure which is composed of the following steps:
- Reduced Intensity, non-myeloablative, lymphodepleting induction regimen using Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.
- Bolus high-dose (720,000 IU/kg) IL-2, which will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient.
- Early-stage follow-up until 30 days post-discharge
- Late-stage follow-up, such as CT scans, will be carried out four and twelve weeks after TIL administration, and then every 3 months thereafter for the first year after TIL therapy; for the second year and onwards, as clinically indicated.
Recently 2 new arms were, using the same protocol described above with the following additions:
Arm 2 - TIL-ACT + Anti PD-1 -the addition of 2 doses of Nivolumab fixed dose 480mg, pre and post TIL.
Arm 3 - TIL-ACT with FMT + Anti CTLA4 - the addition of FMT given using colonoscopy once and 2 maintenance doses of 12 orally ingested capsules, concurrently with a single dose of Ipilimumab 1 mg/kg up to 100 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACT TIL | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: TIL, Drug: IL-21. Reduced Intensity, non-myeloablative, lymphodepleting induction regimen using Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.. 2. Preparation and administration of TIL 3. Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient. |
| ACT TIL + Anti PD-1 | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: TIL, Drug: IL-2, Drug: Nivolumab1. Single dose of Nivolumab 480 mg fixed dose 2. Reduced Intensity, non-myeloablative, lymphodepleting induction regimen using Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.. 3. Preparation and administration of TIL 4. Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient. 5. Second dose of Nivolumab 480 mg fixed dose (at least 4 weeks from the first dose) |
| ACT TIL FMT + Anti CTLA4 | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: TIL, Drug: IL-2, Drug: Ipilimumab, Drug: FMT Protocol1. FMT loading dose given via colonoscopy 2. FMT 12 oral capsules as maintenance - given 2 times 3. Single dose of Ipilimumab 1mg/kg up to 100 mg 4. Reduced Intensity, non-myeloablative, lymphodepleting induction regimen using Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.. 5. Preparation and administration of TIL 6. Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Measurable metastatic Melanoma with at least one lesion that is resectable for TIL generation.
- Refractory to standard treatment
- Patients with one or more brain metastases less than 1 cm each, and any patients with 1 or 2 brain metastases greater than 1 cm must have been treated and stable for 6 weeks.
- Greater than or equal to 18 years of age.
- Willing to practice birth control from the start of chemotherapy until 120 days after release from the hospital.
Key exclusion criteria (10 listed)
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the non-myeloablative, lymphodepleting induction regimen on the fetus or infant.
- Systemic steroid therapy required.
- Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, as evidenced by a positive stress thallium or comparable test, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
- Opportunistic infections (the experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
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 |
|---|---|---|
| FludarabineCyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d. | Drug | ACT TIL, ACT TIL + Anti PD-1, ACT TIL FMT + Anti CTLA4 |
| CyclophosphamideCyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d. | Drug | ACT TIL, ACT TIL + Anti PD-1, ACT TIL FMT + Anti CTLA4 |
| TILTIL administration | Biological | ACT TIL, ACT TIL + Anti PD-1, ACT TIL FMT + Anti CTLA4 |
| IL-2Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient. | Drug | ACT TIL, ACT TIL + Anti PD-1, ACT TIL FMT + Anti CTLA4 |
| NivolumabNivolumab 480 mg fixed dose | Drug | ACT TIL + Anti PD-1 |
| IpilimumabIpilimumab 1 mg/kg up to 100 mg | Drug | ACT TIL FMT + Anti CTLA4 |
| FMT ProtocolFMT given both directly into the colon via colonoscopy and orally using capsules (12 capsules each time). FMT will be taken from melanoma patients treated with Anti PD-1 who achieved a durable response of more than 12 months. | Drug | ACT TIL FMT + Anti CTLA4 |
Primary outcome
Objective tumor responses
Time frame: 3 years
Radiological follow up via CT to determine the sum of Complete Responders (CR) + Partial Responders (PR) + Stable Disease (SD) as assessed by RECIST 1.1
Assess adverse events using NCI CTCAE v4.03 during treatment and follow-up
Time frame: 3 years
Adverse events will be assessed using NCI CTCAE v4.03 during treatment and follow-up
4 secondary outcomes
Overall Survival (OS)
Time frame: 3 years
Response Rate (RR)
Time frame: 3 years
Progression-Free Survival (PFS)
Time frame: 3 years
Quality of Life (QoL)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 33990415Nissani A, Lev-Ari S, Meirson T, Jacoby E, Asher N, Ben-Betzalel G, Itzhaki O, Shapira-Frommer R, Schachter J, Markel G, Besser MJ. Comparison of non-myeloablative lymphodepleting preconditioning regimens in patients undergoing adoptive T cell therapy. J Immunother Cancer. 2021 May;9(5):e001743. doi: 10.1136/jitc-2020-001743.
- Individual participant dataSharing planned: Undecided. To be considered
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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.
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 Fludarabine, Cyclophosphamide and TIL in people with Malignant Melanoma Stage IV, run by Sheba Medical Center at 1 site in Israel.
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 14 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Jan 2023. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meital Bar (972-3-5305201, meiral.bar@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective tumor responses (time frame: 3 years). 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?
On the ClinicalTrials.gov record for NCT03166397, which also lists 1 linked publication.
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 26 Jan 2023.