Hodgkin LymphomaPhase 2NCT04938232
Ipilimumab With or Without Nivolumab in Relapsed/Refractory cHL
A Phase 2 study testing Nivolumab and Ipilimumab in people with Hodgkin Lymphoma and Relapsed Hodgkin's Disease, Adult, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
This study is looking at the effects of Ipilimumab when it is given alone or in combination with Nivolumab to patients with relapsed or refractory classic Hodgkin's lymphoma (cHL). The names of the study drugs involved in this study are: Ipilimumab Nivolumab Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Relapsed Hodgkin's Disease, Adult, Refractory Hodgkin Lymphoma
- What is being tested?
- Nivolumab and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Jun 2021to 1 Aug 2027
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have histologically determined classic Hodgkin lymphoma with pathologic review at the participating institution.
- Participants must have measurable disease, defined as a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT, PET/CT, or MR. Imaging must have been completed no greater than 6 weeks prior to study enrollment. Measurable disease that has previously been irradiated is permissible only if there has been evidence of progression since the radiation.
- Patients must have progressed after two or more lines of systemic treatment, including autologous stem cell transplantation, if eligible.
- Progression of disease or relapse following treatment with nivolumab or pembrolizumab. Intervening treatments with between PD-1 mAb therapy and the trial are permitted.
- Patients may have had a prior autologous stem cell transplant and may have been treated with chimeric antigen receptor T-cells (CAR T-cells).
- Age ≥18 years.
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- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (see Appendix A)
- Adequate hematologic and organ function as defined below:
- Absolute neutrophil count > 1.0x109/L unless due to marrow involvement by lymphoma in which case ANC must be >0.75x109/L. Growth factor support is allowed provided it is received at least 5 days prior to enrollment labs.
- Platelets > 75 x109/L, unless due to marrow involvement by lymphoma, in which case platelets must be >50 x109/L
- Estimated GFR (by Cockroft-Gault equation) > 40ml/min
- Total bilirubin < 1.5 X ULN
- AST/ALT < 2.5 X ULN
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to provide pre-treatment tumor sample by core needle or excisional surgical biopsy. An archival sample is acceptable in the following situations: the sample was acquired within 90 days of initiation of PD-1 therapy AND the following provisions are met: 1) availability of a tumor-containing formalin fixed, paraffin embedded (FFPE) tissue block, 2) if the tumor containing FFPE tissue block cannot be provided in total, sections from this block should be provided that are freshly cut and mounted on positively charged glass slides (SuperFrost Plus are recommended). Preferably, 25 slides should be provided; if not possible, a minimum of 15 slides is required. Exceptions to this criterion may be made with approval of the Study Chair.
- Willingness to use contraception during and after study treatment. Women of child-baring potential (WOCBP) will be instructed to adhere to contraception for a period of 5 months following last dose of nivolumab and 6 months following the last dose of ipilimumab. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after last dose of nivolumab and 6 months after the last dose of ipilimumab.
Who cannot join
- Patients currently receiving anticancer therapies or who have received anticancer therapies within 28 days of the start of study drug (including chemotherapy, radiation therapy, antibody-based therapy, etc.), or 56 days for radioimmunotherapy. Steroids for symptom palliation are allowed but must be either discontinued or on stable doses of < 10mg daily of prednisone (or the equivalent) at the time of initiation of protocol therapy.
- Patients may not be receiving any other investigational agents or have received investigational agents within 4 weeks (or 3 half-lives, whichever is longer) of beginning treatment.
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy unless in consultation with an allergy specialist they are deemed eligible for retreatment with desensitization.
- Patients who have undergone prior allogeneic stem cell transplantation
- Patients with a history of or active autoimmune disease (except controlled asthma, Hashimoto thyroiditis, atopic dermatitis, or vitiligo), or requiring systemic corticosteroids at a dose of 10mg prednisone equivalent daily. Patients with a history of autoimmune disease who never required corticosteroids and with no evidence of disease activity, and in whom the risk of reactivation is felt not to be serious, may be enrolled after discussion with the overall study chair. Exceptions to this are patients with a history of inflammatory bowel disease (ulcerative colitis and Crohn's disease). These patients are excluded regardless of whether their disease is active or inactive.
- Patients who experienced grade 4 immune-related adverse events (irAEs) during treatment with a PD-1 mAb.
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- Patients with active pneumonitis or colitis, or patients with cirrhosis.
- Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia).
- Patients with known HIV infection or hepatitis B or C infection. Testing for HIV is optional. Testing for hepatitis B and C is mandatory. Patients with hepatitis B core Ab positivity but negative surface antigen and negative viral load may be enrolled if they can be treated with a prophylactic agent (eg, entecavir); patients with hepatitis C seropositivity who have a negative viral load can also be enrolled.
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- Prior history of another malignancy (except for non-melanoma skin cancer or in situ cervical or breast cancer) unless disease free for at least 2 years. Patients with prostate cancer are allowed if PSA is less than 1.
- Patients should not have received immunization with attenuated live vaccine within one week of study entry or during study period.
- History of noncompliance to medical regimens.
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
- Patients with any one of the following currently on or in the previous 6 months will be excluded: myocardial infarction, congenital long QT syndrome, torsade de pointes, left anterior hemiblock, unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident.
- Other uncontrolled intercurrent illness that would limit adherence to study requirements.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: A Phase II Trial of Ipilimumab With and Without Nivolumab in Patients With Relapsed/Refractory Classic Hodgkin Lymphoma
This study is looking at the effects of Ipilimumab when it is given alone or in combination with Nivolumab to patients with relapsed or refractory classic Hodgkin's lymphoma (cHL).
The names of the study drugs involved in this study are:
- Ipilimumab
- Nivolumab
Read the detailed description
This is an open-label, multi-center, phase II study of ipilimumab with or without nivolumab for patients with relapsed or refractory (R/R) classic Hodgkin lymphoma (cHL).
Nivolumab is a drug which is approved by the United States Food and Drug Administration (FDA) for the treatment of adult patients experiencing relapsed Hodgkin lymphoma (cHL) who have received at least two prior systemic therapies.
Ipilimumab has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced kidney cancers.
The study drugs have not been approved in combination for cHL by the Food and Drug Administration (FDA). This study is for participants who previously had progressive disease when receiving a PD-1 mAb.
Participants will receive 4 cycles of ipilimumab monotherapy and then undergo restaging imaging. Patients who achieved an objective response will continue treatment with ipilimumab maintenance. Other patients will receive 4 cycles of nivolumab and ipilimumab followed by ipilimumab maintenance treatment. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are eligible to proceed to combination therapy with nivolumab and ipilimumab if they are clinically stable. Participants will receive up to ~ 24 months of study treatment.
After completion of therapy, participants will be followed every 3 months for 2 years and then every 6 months for the next 5 years.
It is expected that about 13 people will participate in this research study.
Bristol Myers Squibb (BMS) is supporting this research study by providing the study drugs and funding for the study.
- Being tested
- Nivolumab, Ipilimumab
- Keywords
- Hodgkin lymphoma, Relapsed Hodgkin's Disease, Adult, Refractory Hodgkin Lymphoma
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Intravenous infusion
IpilimumabDrug
Also called Yervoy
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Disease Progression after previous therapy | Experimental | Participants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable.
* Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles
* Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles
* Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles Receives: Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Patients achieving a complete (CR) or partial response (PR), assessed by PET/CT (using Lugano)
Measured: From enrollment to completion of 4 cycles (each cycle is 21 days) of treatment
Secondary outcomes (11)
Overall Response Rate (ORR) Ipilimumab Monotherapy, Lugano
Patients achieving complete (CR) or partial response (PR), assessed by PET/CT (using Lugano criteria) after ipilimumab monotherapy
Measured: 12 weeks
Overall Response Rate (ORR) Ipilimumab Monotherapy, LYRIC
Patients achieving complete (CR) or partial response (PR), assessed by PET/CT (using LYRIC criteria) after ipilimumab monotherapy
Measured: 12 weeks
Complete Response Rate (CRR) Ipilimumab Monotherapy, Lugano
Patients achieving complete response (CR), assessed by PET/CT (using Lugano criteria) after ipilimumab monotherapy
Measured: 12 weeks
Complete Response Rate (CRR) Ipilimumab Monotherapy, LYRIC
Patients achieving complete response (CR), assessed by PET/CT (using Lugano criteria) after ipilimumab monotherapy
Measured: 12 weeks
Overall Response Rate (ORR) Ipilimumab and Nivolumab Combination Therapy, Lugano
Patients achieving complete (CR) or partial response (PR), assessed by PET/CT (using Lugano criteria) after ipilimumab and nivolumab combination therapy
Measured: 24 weeks
Overall Response Rate (ORR) Ipilimumab and Nivolumab Combination Therapy, LYRIC
Patients achieving complete (CR) or partial response (PR), assessed by PET/CT (using Lugano criteria) after ipilimumab and nivolumab combination therapy
Measured: 24 weeks
Progression-free Survival, LYRIC
Percent of patients alive and progression-free at 2-years. Time from registration to progression or death, censored at date last known alive and progression-free using LYRIC criteria
Measured: 2 years
Duration of Response
2-year percent DOR using Lugano criteria (LYRIC was equivalent). Time from first response (PR or CR) to progression, censored at last disease assessment.
Measured: 2 years
Progression-free Survival, Lugano
Percent of patients alive and progression-free at 2-years. Time from registration to progression or death, censored at date last known alive and progression-free using Lugano criteria
Measured: 2 years
Overall Survival
Percent OS at 2-years. Time from registration to death from any cause, censored at date last known alive
Measured: 2 years
Percent of Patients With Grade 3+ Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Worst grade adverse event attributable (possibly, probably, definitely) to study treatment. Descriptions and grading scales per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start4 Jun 2021
- Primary completion1 Apr 2024
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Reid Merryman, MD, Dana-Farber Cancer Institute
- Investigators
- Reid W Merryman, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938232
- Sponsor's protocol ID
- 21-204
- Status last verified
- Aug 2026
- First submitted
- 8 Jun 2021
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Ipilimumab With and Without Nivolumab in Patients With Relapsed/Refractory Classic Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT04938232
- Acronym / sponsor ID
- 21-204
- Keywords
- Hodgkin lymphoma, Relapsed Hodgkin's Disease, Adult, Refractory Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 24 Jun 2021 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is looking at the effects of Ipilimumab when it is given alone or in combination with Nivolumab to patients with relapsed or refractory classic Hodgkin's lymphoma (cHL).
The names of the study drugs involved in this study are:
- Ipilimumab
- Nivolumab
Detailed description
This is an open-label, multi-center, phase II study of ipilimumab with or without nivolumab for patients with relapsed or refractory (R/R) classic Hodgkin lymphoma (cHL).
Nivolumab is a drug which is approved by the United States Food and Drug Administration (FDA) for the treatment of adult patients experiencing relapsed Hodgkin lymphoma (cHL) who have received at least two prior systemic therapies.
Ipilimumab has been approved by the FDA for the treatment of metastatic melanoma (a type of skin cancer), and specific types of previously treated advanced kidney cancers.
The study drugs have not been approved in combination for cHL by the Food and Drug Administration (FDA). This study is for participants who previously had progressive disease when receiving a PD-1 mAb.
Participants will receive 4 cycles of ipilimumab monotherapy and then undergo restaging imaging. Patients who achieved an objective response will continue treatment with ipilimumab maintenance. Other patients will receive 4 cycles of nivolumab and ipilimumab followed by ipilimumab maintenance treatment. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are eligible to proceed to combination therapy with nivolumab and ipilimumab if they are clinically stable. Participants will receive up to ~ 24 months of study treatment.
After completion of therapy, participants will be followed every 3 months for 2 years and then every 6 months for the next 5 years.
It is expected that about 13 people will participate in this research study.
Bristol Myers Squibb (BMS) is supporting this research study by providing the study drugs and funding for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disease Progression after previous therapy | Experimental | Drug: Nivolumab, Drug: IpilimumabParticipants will receive Ipilimumab alone and depending on response will receive either a maintenance course of Ipilimumab or a course of Nivolumab and Ipilimumab in combination followed by a maintenance course of Ipilimumab. Patients who have progressive disease after fewer than 4 cycles of ipilimumab are also eligible to proceed to combination therapy with nivolumab and ipilimumab, if they are clinically stable. * Ipilimumab Monotherapy: Every 3 weeks for 4 study cycles * Complete Response/Partial Response: Maintenance Ipilimumab every 12 weeks for 8 cycles * Stable or Progressive Disease Response: Nivolumab and Ipilimumab every 3 weeks for 4 study cycles, followed by Maintenance Ipilimumab every 12 weeks for 7 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically determined classic Hodgkin lymphoma with pathologic review at the participating institution.
- Participants must have measurable disease, defined as a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT, PET/CT, or MR. Imaging must have been completed no greater than 6 weeks prior to study enrollment. Measurable disease that has previously been irradiated is permissible only if there has been evidence of progression since the radiation.
- Patients must have progressed after two or more lines of systemic treatment, including autologous stem cell transplantation, if eligible.
- Progression of disease or relapse following treatment with nivolumab or pembrolizumab. Intervening treatments with between PD-1 mAb therapy and the trial are permitted.
- Patients may have had a prior autologous stem cell transplant and may have been treated with chimeric antigen receptor T-cells (CAR T-cells).
Key exclusion criteria (16 listed)
- Patients currently receiving anticancer therapies or who have received anticancer therapies within 28 days of the start of study drug (including chemotherapy, radiation therapy, antibody-based therapy, etc.), or 56 days for radioimmunotherapy. Steroids for symptom palliation are allowed but must be either discontinued or on stable doses of < 10mg daily of prednisone (or the equivalent) at the time of initiation of protocol therapy.
- Patients may not be receiving any other investigational agents or have received investigational agents within 4 weeks (or 3 half-lives, whichever is longer) of beginning treatment.
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy unless in consultation with an allergy specialist they are deemed eligible for retreatment with desensitization.
- Patients who have undergone prior allogeneic stem cell transplantation
- Patients with a history of or active autoimmune disease (except controlled asthma, Hashimoto thyroiditis, atopic dermatitis, or vitiligo), or requiring systemic corticosteroids at a dose of 10mg prednisone equivalent daily. Patients with a history of autoimmune disease who never required corticosteroids and with no evidence of disease activity, and in whom the risk of reactivation is felt not to be serious, may be enrolled after discussion with the overall study chair. Exceptions to this are patients with a history of inflammatory bowel disease (ulcerative colitis and Crohn's disease). These patients are excluded regardless of whether their disease is active or inactive.
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: OpdivoIntravenous infusion | Drug | Disease Progression after previous therapy |
| IpilimumabAlso: YervoyIntravenous infusion | Drug | Disease Progression after previous therapy |
Primary outcome
Overall Response Rate (ORR)
Time frame: From enrollment to completion of 4 cycles (each cycle is 21 days) of treatment
Patients achieving a complete (CR) or partial response (PR), assessed by PET/CT (using Lugano)
11 secondary outcomes
Overall Response Rate (ORR) Ipilimumab Monotherapy, Lugano
Time frame: 12 weeks
Overall Response Rate (ORR) Ipilimumab Monotherapy, LYRIC
Time frame: 12 weeks
Complete Response Rate (CRR) Ipilimumab Monotherapy, Lugano
Time frame: 12 weeks
Complete Response Rate (CRR) Ipilimumab Monotherapy, LYRIC
Time frame: 12 weeks
Overall Response Rate (ORR) Ipilimumab and Nivolumab Combination Therapy, Lugano
Time frame: 24 weeks
Overall Response Rate (ORR) Ipilimumab and Nivolumab Combination Therapy, LYRIC
Time frame: 24 weeks
Progression-free Survival, LYRIC
Time frame: 2 years
Duration of Response
Time frame: 2 years
Progression-free Survival, Lugano
Time frame: 2 years
Overall Survival
Time frame: 2 years
Percent of Patients With Grade 3+ Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Reid W Merryman, MD principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Ipilimumab in people with Hodgkin Lymphoma and Relapsed Hodgkin's Disease, Adult, run by Dana-Farber Cancer Institute at 4 sites 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 16 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (ORR) (time frame: From enrollment to completion of 4 cycles (each cycle is 21 days) of treatment). 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 16 Sep 2026.