MelanomaPhase 2NCT04526730
Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients
A Phase 2 study testing Tavo, Nivolumab and OncoSec Medical Electroporation Therapy System in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This is a Phase 2 open-label, single-arm study of neoadjuvant treatment of intratumoral tavo-EP plus nivolumab IV infusion. Eligible participants will be those with pathological diagnosis of operable locally-regionally advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Tavo, Nivolumab and OncoSec Medical Electroporation Therapy System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2020to 22 May 2025
- 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
- Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent
- Histologic diagnosis of melanoma
- Must be considered surgically operable and may present as any of the following groups:
- Primary melanoma with clinically apparent regional lymph node metastases, confirmed by pathological diagnosis.
- Clinically detected recurrence of melanoma at regional lymph node basin(s), confirmed by pathological diagnosis.
- Clinically or histologically detected primary melanoma involving multiple regional nodal groups, confirmed by pathological diagnosis.
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- Clinically detected single site of nodal metastatic melanoma arising from an unknown primary, confirmed by pathological diagnosis.
- Participants with in transit or satellite metastases with or without lymph node involvement are allowed if they are considered surgically resectable at Screening by the treating surgical oncologist.
- Participants with distant cutaneous/subcutaneous, soft tissue or nodal metastases with or without regional lymph node involvement are allowed if they are considered potentially surgically resectable and can be biopsied at Screening by the treating surgical oncologist. Elevated LDH is not an exclusion.
- Participants are eligible for this study either at presentation for primary melanoma with concurrent regional nodal and/or in-transit or distant metastasis, or at the time of clinically detected nodal, in transit, or distant recurrence
- Participants must be evaluated by standard-of-care full body imaging studies including positron emission tomography - computed tomography (PET-CT ;preferred; including diagnostic CT component if possible) or CT (if PET-CT cannot be done) as well as magnetic resonance imaging (MRI) of the brain (or CT if MRI cannot be done) as part of the initial clinical work-up at Screening (no more than 4 weeks prior to Cycle 1, Day 1).
- Have measurable disease based on RECIST v1.1, with at least one anatomically distinct lesion. Lesion or lesions must meet all the following baseline criteria:
- Accessible for electroporation
- Must be measured in at least one dimension (longest diameter in the plane of measurement is to be recorded)
- Greater than 3 mm
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male Participants: Male subjects of childbearing potential must be surgically sterile, or must agree to use adequate method of contraception during the study and at least 5 months following the last day of study drug administration. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
- Female participants: Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and 5 months following last day study drug administration (either tavo or nivolumab); acceptable methods include hormonal contraception (oral contraceptives - as long as on stable dose, patch, implant, and injection), intrauterine devices, or double barrier methods (e.g. vaginal diaphragm/vaginal sponge plus condom, or condom plus spermicidal jelly), sexual abstinence or a vasectomized partner. Women may be surgically sterile or at least 1-year post-last menstrual period. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
Who cannot join
- Participant has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Also, includes patients who are considered disease-free for at least 3 years from the last definitive treatment for a second malignancy.
- Participants who have Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies at Screening). HIV testing at screening is not required unless considered clinically indicated by the treating physician.
- Participants who have active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected at Screening); Note: Participants who have been vaccinated against Hepatitis B and who are positive only for the Hepatitis B surface antibody are permitted to participate in the study. Hepatitis B and C testing at screening is not required unless considered clinically indicated by the treating physician.
- Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Principal Investigator.
- Participant has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Participant has a history of interstitial lung disease.
Show all 19Show fewer
- Participant has an active infection requiring systemic therapy.
- Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Participant has not recovered (i.e., > Grade 1 at Cycle 1, Day 1) from AEs due to a previously administered agent.
- Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Participants who are pregnant or breast feeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 5 months after the last dose of trial treatment.
- Participants with electronic pacemakers or defibrillators
- Participants who have received a live-virus vaccination within 30 days of the first dose of treatment. Seasonal flu vaccines that do not contain live virus are permitted
- Participants who have received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Cycle 1, Day 1.
- Previous treatment with anti-PD1 or anti-PDL1 immunotherapy.
- Participation in another clinical study and systemic therapy within 30 days of Cycle 1, Day 1.
- ECOG Performance Status: >1
- Inadequate organ function as defined per protocol
- Participant has severe hypersensitivity (≥Grade 3) to nivolumab and/or any of its excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Immunotherapy With Intratumoral Tavokinogene Telseplasmid (Tavo) Plus Electroporation in Combination With Intravenous Nivolumab in Patients With Operable Locally- Regionally Advanced Melanoma
This is a Phase 2 open-label, single-arm study of neoadjuvant treatment of intratumoral tavo-EP plus nivolumab IV infusion. Eligible participants will be those with pathological diagnosis of operable locally-regionally advanced melanoma.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TavoDrug
Tavo will be injected on Days 1 and 8 every 4 weeks at a dose volume of ¼ of the calculated lesion volume with a minimum dose volume per lesion of 0.1 mL for lesions of volume <0.4 cm3
NivolumabDrug
Nivolumab will be administered 480 mg every 4 weeks over 30 minute infusions
OncoSec Medical Electroporation Therapy SystemDevice
Also called Electroporation
The OMS (OncoSec Medical Electroporation Therapy System), a medical EP device system, consists of 3 components: 1. an Electroporation Generator that generates electric pulses, 2. a sterile Applicator Tip containing needle array, and 3. an Applicator Handle that connects to the Electroporation Generator at the proximal end and connects to the Applicator Tip at the distal end.
Upon user activation of the attached Foot Switch, the OMS Electroporation Generator delivers controlled electrical pulses in a square wave pulse pattern yielding optimal transmembrane potential for electroporation to occur. EP pulses occur between 6 hexagonal opposing needle electrodes. After the first pulse, the polarity between the opposing needle electrode pairs is reversed and the needle pair is pulsed again. After the initial paired pulse, the pulse delivery is rotated clockwise to the next opposing needle pairs until a total of 6 pulses are delivered to complete the EP sequence.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Treatment | Experimental | Neoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion).
Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist.
Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase. Receives: Drug: Tavo; Drug: Nivolumab; Device: OncoSec Medical Electroporation Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response
For each subject, the study intervention consists of 3 phases: (1) Neoadjuvant Phase; (2) Surgery Phase; (3) Adjuvant Phase. Completion of all 3 phases is required for primary completion of the study. The study protocol requires that all subjects will be followed for 4 weeks after last dose of nivolumab at End of Study (EOS) visit. That is 4 weeks after the conclusion of the adjuvant phase. For the purpose of reporting the primary outcome measure, Pathologic Complete Response will be estimated based on the proportion of participants who have completed the study phases and were found to have no viable tumor on histologic assessment at definitive surgery after the 12- week Neoadjuvant phase. Surgery will then be scheduled 2-4 weeks after neoadjuvant phase. This will be followed by the adjuvant phase. Therefore, the proportion of participants who continue in Pathologic Complete Response following completion of the 3 study phases would be reported.
Measured: At least four weeks after the last dose of nivolumab at End of Study (EOS) visit
Secondary outcomes (4)
Objective Response Rate
Preoperative ORR assessed by Investigator based on RECIST v1.1 at the conclusion of the Neoadjuvant phase.
Measured: Conclusion of the neoadjuvant phase.
Relapse Free Survival
RFS assessed by Investigator based on RECIST v1.1 at least four weeks after the last dose of nivolumab at End of Study (EOS) visit.
Measured: At least four weeks after the last dose of nivolumab at End of Study (EOS) visit
Overall Survival
Overall survival at 1 year after start of therapy.
Measured: At 1 year after start of therapy
Risk of Surgical Delay
Definitive surgery will be planned at about 12 weeks. Participants will be monitored for surgical delay (either due to toxicity and/or tumor progression). Defined as the number of participants who had Surgery delayed due to progression.
Measured: Up to 16 weeks after start or therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start22 Dec 2020
- Primary completion26 Mar 2024
- Study completion22 May 2025
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research 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
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- OncoSec Medical Incorporated
- Responsible party
- Sponsor
- Investigators
- Ahmad Tarhini, MD, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526730
- Sponsor's protocol ID
- MCC-20313
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2020
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tarhini AA, Eroglu Z, Eljilany I, Zager JS, Gonzalez RJ, Sarnaik AA, Cruse CW, Khushalani NI, De Aquino DB, Abraham E, Acevedo DM, Richards A, Schell MJ, Kalos D, Chen PL, Messina JL, Canton DA, Sondak VK. Neoadjuvant Intratumoral Plasmid IL-12 Electro-Gene-Transfer and Nivolumab in Patients with Operable, Locoregionally Advanced Melanoma. Clin Cancer Res. 2024 Dec 2;30(23):5333-5341. doi: 10.1158/1078-0432.CCR-24-2768.
PubMed 39417680Jacobs L, Yshii L, Junius S, Geukens N, Liston A, Hollevoet K, Declerck P. Intratumoral DNA-based delivery of checkpoint-inhibiting antibodies and interleukin 12 triggers T cell infiltration and anti-tumor response. Cancer Gene Ther. 2022 Jul;29(7):984-992. doi: 10.1038/s41417-021-00403-8. Epub 2021 Nov 9.
PubMed 34754076
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Immunotherapy With Intratumoral Tavokinogene Telseplasmid (Tavo) Plus Electroporation in Combination With Intravenous Nivolumab in Patients With Operable Locally- Regionally Advanced Melanoma
- ClinicalTrials.gov ID
- NCT04526730
- Acronym / sponsor ID
- MCC-20313
- Conditions
- Melanoma
- Keywords
- Skin Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- OncoSec Medical Incorporated
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Posted 6 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 open-label, single-arm study of neoadjuvant treatment of intratumoral tavo-EP plus nivolumab IV infusion. Eligible participants will be those with pathological diagnosis of operable locally-regionally advanced melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Treatment | Experimental | Drug: Tavo, Drug: Nivolumab, Device: OncoSec Medical Electroporation Therapy SystemNeoadjuvant Phase: (3 x 4-week cycles, total 12 weeks): At every cycle, intratumoral tavo-EP will be administered (on Days 1 and 8) concurrently with 480 mg nivolumab IV infusion on Day 8 of each cycle (tavo-EP will be administered prior to nivolumab infusion). Definitive Surgery Phase: Surgery may be scheduled about 2-4 weeks after the last dose of nivolumab following radiologic and clinical assessment at that point. Pathologic response will be determined by institutional pathologist. Adjuvant Phase: Adjuvant therapy with nivolumab monotherapy will begin approximately 2-4 weeks following definitive surgery; recovery from surgery is required (Day 1 of Cycle 4 will be determined by the treating investigator once the subject is cleared to initiate systemic therapy). Nivolumab (480 mg IV infusion on Day 1 of each 4-week cycle) will be administered for up to 9 cycles during the Adjuvant phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent
- Histologic diagnosis of melanoma
- Must be considered surgically operable and may present as any of the following groups:
- Participants are eligible for this study either at presentation for primary melanoma with concurrent regional nodal and/or in-transit or distant metastasis, or at the time of clinically detected nodal, in transit, or distant recurrence
- Participants must be evaluated by standard-of-care full body imaging studies including positron emission tomography - computed tomography (PET-CT ;preferred; including diagnostic CT component if possible) or CT (if PET-CT cannot be done) as well as magnetic resonance imaging (MRI) of the brain (or CT if MRI cannot be done) as part of the initial clinical work-up at Screening (no more than 4 weeks prior to Cycle 1, Day 1).
Key exclusion criteria (19 listed)
- Participant has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Also, includes patients who are considered disease-free for at least 3 years from the last definitive treatment for a second malignancy.
- Participants who have Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies at Screening). HIV testing at screening is not required unless considered clinically indicated by the treating physician.
- Participants who have active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected at Screening); Note: Participants who have been vaccinated against Hepatitis B and who are positive only for the Hepatitis B surface antibody are permitted to participate in the study. Hepatitis B and C testing at screening is not required unless considered clinically indicated by the treating physician.
- Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Principal Investigator.
- Participant has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
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 |
|---|---|---|
| TavoTavo will be injected on Days 1 and 8 every 4 weeks at a dose volume of ¼ of the calculated lesion volume with a minimum dose volume per lesion of 0.1 mL for lesions of volume <0.4 cm3 | Drug | Neoadjuvant Treatment |
| NivolumabNivolumab will be administered 480 mg every 4 weeks over 30 minute infusions | Drug | Neoadjuvant Treatment |
| OncoSec Medical Electroporation Therapy SystemAlso: ElectroporationThe OMS (OncoSec Medical Electroporation Therapy System), a medical EP device system, consists of 3 components: 1. an Electroporation Generator that generates electric pulses, 2. a sterile Applicator Tip containing needle array, and 3. an Applicator Handle that connects to the Electroporation Generator at the proximal end and connects to the Applicator Tip at the distal end. Upon user activation of the attached Foot Switch, the OMS Electroporation Generator delivers controlled electrical pulses in a square wave pulse pattern yielding optimal transmembrane potential for electroporation to occur. EP pulses occur between 6 hexagonal opposing needle electrodes. After the first pulse, the polarity between the opposing needle electrode pairs is reversed and the needle pair is pulsed again. After the initial paired pulse, the pulse delivery is rotated clockwise to the next opposing needle pairs until a total of 6 pulses are delivered to complete the EP sequence. | Device | Neoadjuvant Treatment |
Primary outcome
Pathologic Complete Response
Time frame: At least four weeks after the last dose of nivolumab at End of Study (EOS) visit
For each subject, the study intervention consists of 3 phases: (1) Neoadjuvant Phase; (2) Surgery Phase; (3) Adjuvant Phase. Completion of all 3 phases is required for primary completion of the study. The study protocol requires that all subjects will be followed for 4 weeks after last dose of nivolumab at End of Study (EOS) visit. That is 4 weeks after the conclusion of the adjuvant phase. For the purpose of reporting the primary outcome measure, Pathologic Complete Response will be estimated based on the proportion of participants who have completed the study phases and were found to have no viable tumor on histologic assessment at definitive surgery after the 12- week Neoadjuvant phase. Surgery will then be scheduled 2-4 weeks after neoadjuvant phase. This will be followed by the adjuvant phase. Therefore, the proportion of participants who continue in Pathologic Complete Response following completion of the 3 study phases would be reported.
4 secondary outcomes
Objective Response Rate
Time frame: Conclusion of the neoadjuvant phase.
Relapse Free Survival
Time frame: At least four weeks after the last dose of nivolumab at End of Study (EOS) visit
Overall Survival
Time frame: At 1 year after start of therapy
Risk of Surgical Delay
Time frame: Up to 16 weeks after start or therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39417680Tarhini AA, Eroglu Z, Eljilany I, Zager JS, Gonzalez RJ, Sarnaik AA, Cruse CW, Khushalani NI, De Aquino DB, Abraham E, Acevedo DM, Richards A, Schell MJ, Kalos D, Chen PL, Messina JL, Canton DA, Sondak VK. Neoadjuvant Intratumoral Plasmid IL-12 Electro-Gene-Transfer and Nivolumab in Patients with Operable, Locoregionally Advanced Melanoma. Clin Cancer Res. 2024 Dec 2;30(23):5333-5341. doi: 10.1158/1078-0432.CCR-24-2768.
- Derived from this study: PubMed 34754076Jacobs L, Yshii L, Junius S, Geukens N, Liston A, Hollevoet K, Declerck P. Intratumoral DNA-based delivery of checkpoint-inhibiting antibodies and interleukin 12 triggers T cell infiltration and anti-tumor response. Cancer Gene Ther. 2022 Jul;29(7):984-992. doi: 10.1038/s41417-021-00403-8. Epub 2021 Nov 9.
- Individual participant dataSharing planned: Undecided
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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.
Ahmad Tarhini, MD, PhD principal investigator
Moffitt Cancer Center
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 Tavo, Nivolumab and OncoSec Medical Electroporation Therapy System in people with Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 19 inclusion and 19 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 29 Jun 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?
Yes. Results are posted in the registry (first posted 6 May 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?
Pathologic Complete Response (time frame: At least four weeks after the last dose of nivolumab at End of Study (EOS) visit). 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 NCT04526730, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.