A Phase 2 interventional study of Sacituzumab Tirumotecan (sac-TMT) in Vaginal Squamous Cell Carcinoma and Vulvar Squamous Cell Carcinoma, sponsored by Latin American Cooperative Oncology Group. Not yet recruiting at 12 sites in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Latin American Cooperative Oncology Group · Phase 2, Interventional, and Treatment
The ARCANA trial (LACOG 1724) is a single-arm, non-randomized, multi-center, parallel, two-cohort Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT, MK-2870) as a second-line or subsequent treatment in patients with advanced or metastatic vaginal and vulvar squamous cell carcinomas. Given the rarity of these cancers and the lack of standard second-line therapies, this study explores sac-TMT, a novel TROP-2-directed antibody-drug conjugate (ADC). TROP-2 is highly expressed in both vulvar and vaginal squamous cell carcinomas, making it a promising therapeutic target.
RATIONALE AND MOLECULAR TARGETING
Advanced and metastatic vulvar and vaginal squamous cell carcinomas share pathophysiological features with cervical cancer, including high rates of Human Papillomavirus (HPV) driver oncogenesis and robust expression of Trophoblast Cell Surface Antigen 2 (TROP-2). Sacituzumab tirumotecan (sac-TMT, MK-2870) is a novel TROP-2-directed antibody-drug conjugate (ADC) composed of a humanized anti-TROP2 IgG1 monoclonal antibody linked via a methyl sulfonyl moiety to a potent topoisomerase 1 inhibitor payload (KL610023). Upon binding to TROP-2 on tumor cells, sac-TMT internalizes and releases its payload, inducing cell cycle arrest and apoptosis while exerting bystander-killing and antibody-dependent cellular cytotoxicity.
DREAM STUDY DESIGN AND STATISTICAL CONSIDERATIONS
This Phase II study utilizes a Simon's two-stage Minimax design for each independent cohort (Cohort A: Vagina; Cohort B: Vulva) to control the familywise alpha level at 0.05 (one-sided) with 80% power:
Stage 1: 12 participants per cohort will be enrolled. An interim analysis for futility will be conducted; if 0 responses are observed in Stage 1, enrollment in that cohort will be halted.
Stage 2: If $\ge 1$ objective response is achieved in Stage 1, an additional 10 participants will be accrued (totaling 22 evaluable patients per cohort, expanded to 24 to account for a 10% dropout rate). A cohort is considered positive if $\ge 4$ responses are observed among evaluable participants.
TREATMENT ADMINISTRATION AND MANDATORY PROPHYLAXISSac-TMT is administered intravenously on Days 1 and 15 of 28-day cycles. Mandatory premedication administered 1.5 hours ($\pm30$ minutes) prior to each infusion includes an H1 receptor antagonist (diphenhydramine or equivalent), acetaminophen, dexamethasone (8-10 mg IV), and an H2 receptor antagonist to minimize infusion-related reactions. To prevent oral mucositis, participants receive mandatory daily prophylactic steroid-containing mouthwash (dexamethasone solution) 4 times daily. Prophylactic artificial tears are also strongly recommended to mitigate ocular surface toxicities.
EXPLORATORY BIOMARKER RESEARCH
The trial incorporates a longitudinal biorepository to identify predictive signatures and resistance mechanisms. Mandatory archival or freshly obtained FFPE tumor tissue blocks/slides collected at baseline will undergo TROP-2 immunohistochemistry (IHC), p16/HPV16 profiling, and high-throughput next-generation sequencing (NGS). Serial blood samples (plasma/PBMCs) collected at baseline and prespecified on-treatment timepoints (Weeks 6, 12, 24, and at disease progression) will evaluate circulating tumor DNA (ctDNA) dynamics and immune cell profiling to monitor treatment response and genomic resistance patterns over time.
Latin American Cooperative Oncology Group is the lead sponsor of 48 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are in Section 8.4.5.
Abstains from breastfeeding during the study intervention period and for at least 10 days after study intervention.
Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.
8. Has provided an sample or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from any site not previously irradiated. Sites should follow local guidelines regarding fresh tissue collection. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slide. Newly obtained biopsies are preferred to archived tissue (recommended 22-28 slides). 9. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.
10. Adequate organ function as defined in the following table (Table 2). Specimens must be collected within 14 days before the start of study intervention.
11. Has performance status of 0 or 1. 12. Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.
13. testing at screening is not required unless there is a known history of HIV infection. HIV-infected participants must have well-controlled HIV on ART, defined as:
Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before enrollment and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong inducers/inhibitors/substrates. Refer to https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer/inhibitor/substrate of CYP3A4.
14. testing at screening is not required unless there is a known history of HBV infection. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before enrollment.
Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.
15. testing at screening is not required unless there is a known history of HCV infection. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
Note: Participants must have completed curative antiviral therapy at least 4 weeks before enrollment.
Exclusion Criteria:
Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring , and/or has had radiation pneumonitis.
Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
Received a live or within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
Refer to Section 6.2 for information on COVID-19 vaccines.
Is currently receiving a strong inducer/inhibitor of that cannot be discontinued for the duration of treatment with study intervention. The required before starting study intervention is 2 weeks.
Note: A list of strong inducers/inhibitors of CYP3A4 can be found at the following website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer/inhibitor of CYP3A4. Prior/Concurrent Clinical Study Experience
Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.
Other Exclusions
Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.
Note: Participants who underwent major surgery must have adequately recovered from toxicity and/or complications from the surgery before starting study intervention.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with advanced or metastatic vaginal squamous cell carcinoma who progressed on or after platinum-based chemotherapy. Participants will receive sacituzumab tirumotecan (sac-TMT, MK-2870) monotherapy at a dose of $4\\text{ mg/kg}$ via intravenous (IV) infusion on Days 1 and 15 of every 28-day cycle. Treatment continues until disease progression, unacceptable toxicity, or for a maximum exposure duration of approximately 2 years.
Drug: Sacituzumab Tirumotecan (sac-TMT)
Participants with advanced or metastatic vulvar squamous cell carcinoma who progressed on or after platinum-based chemotherapy. Participants will receive sacituzumab tirumotecan (sac-TMT, MK-2870) monotherapy at a dose of $4\\text{ mg/kg}$ via intravenous (IV) infusion on Days 1 and 15 of every 28-day cycle. Treatment continues until disease progression, unacceptable toxicity, or for a maximum exposure duration of approximately 2 years.
Drug: Sacituzumab Tirumotecan (sac-TMT)
Sacituzumab tirumotecan is a TROP-2-directed antibody-drug conjugate (ADC) consisting of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase 1 inhibitor payload (KL610023). It will be administered intravenously at a dose of $4\\text{ mg/kg}$ on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity, or up to a maximum duration of approximately 2 years.
Also known as: MK-2870, SKB264
Objective Response Rate (ORR) by Investigator Assessment
Proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by local site investigator/radiology.
Time frame: Up to Week 24
Objective Response Rate by Independent Central Review (ORR-ICR)
Proportion of participants achieving complete response (CR) or partial response (PR) as evaluated by Independent Central Review using RECIST v1.1 criteria.
Time frame: Up to 24 weeks.
Disease Control Rate (DCR)
Proportion of participants achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1 by investigator assessment..
Time frame: Up to 24 weeks.
Duration of Response (DoR)
Time from the first documented evidence of complete response (CR) or partial response (PR) until the date of first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 40 months.
Progression-Free Survival (PFS)
Time from the date of enrollment until the date of first documented disease progression (radiographically or clinically confirmed per RECIST 1.1) by investigator assessment, or death due to any cause, whichever occurs first.
Time frame: Up to approximately 40 months.
Overall Survival (OS)
Time from the date of enrollment to the date of participant death due to any cause.
Time frame: Up to approximately 40 months.
Clinical Benefit Rate (CBR)
Rate, incidence, and severity of treatment-emergent adverse events (AEs) and Grade $\\ge 3$ AEs evaluated according to NCI CTCAE version 5.0, including Adverse Events of Special Interest (AESIs).
Time frame: From enrollment up to 30 days after the last dose of study intervention.
Treatment Compliance
Assessment of treatment modifications, including the proportion and reasons for dose reductions, treatment delays, or permanent discontinuations (e.g., disease progression, AEs, consent withdrawal).
Time frame: Up to approximately 2 years.
Post-Progression Therapies
Descriptive characterization and timing of subsequent anticancer therapies administered after disease progression on sac-TMT.
Time frame: Up to approximately 40 months.
Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Assessment of changes from baseline in global health status, functional domains, and symptom scales evaluated using the EORTC QLQ-C30 core cancer instrument.
Time frame: Baseline and every 6 weeks during treatment up to Week 24.
Health-Related Quality of Life (HRQoL) - EORTC QLQ-VU34
ssessment of changes from baseline in vulvar/vaginal cancer-specific symptoms evaluated using the EORTC QLQ-VU34 questionnaire.
Time frame: Baseline and every 6 weeks during treatment up to Week 24.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Mar 2030, 38 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sacituzumab tirumotecan
Latin American Cooperative Oncology Group