Not yet recruitingRare disease

Study of sacituzumab govitecan versus investigator’s choice drug combination in patients with cancer of unknown primary after platinum‑based chemotherapy failure

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Cancer of unknown primary, a type of cancer where doctors cannot locate the original organ where the tumor started. Participants have already been treated with platinum‑based chemotherapy that did not work or the disease returned. The experimental medication being tested is Sacituzumab govitecan, given by infusion into a vein. For comparison, the study uses a selection of standard chemotherapy drugs chosen by the treating doctor, which may include Cisplatin, Disodium folinate, Gemcitabine, Calcium folinate, Docetaxel, Oxaliplatin, Carboplatin, Paclitaxel or Fluorouracil. All medications are administered intravenously, meaning they are delivered directly into the bloodstream through a needle.

The purpose of the study is to compare the effectiveness and safety of the experimental drug with the doctor‑chosen standard treatments. After enrollment, participants are randomly assigned to receive either the test medication or one of the standard options and then are followed with regular clinic visits to monitor their health, side effects, and any changes in tumor size. Doctors use a set of criteria called RECIST to decide whether the cancer is growing, staying the same, or shrinking, and they track how long patients live without the disease getting worse, which is known as progression‑free survival. Quality of life is also measured using a questionnaire called EORTC QLQ-C30, and participants report any symptoms they experience throughout the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
After you join the study, you will be randomly assigned to receive either the test drug sacituzumab govitecan or one of the standard chemotherapy options selected by the investigator.
Step 2
Receive assigned medication
The medication will be given by intravenous infusion in a clinic setting.
If you are assigned to the test drug, the dose is 10 mg per kilogram of body weight, administered as a solution for infusion.
If you are assigned to a comparator, the possible drugs and their doses are:
- cisplatin: 75 mg per square meter, given by intravenous infusion.
- disodium folinate: 400 mg per square meter, given by intravenous infusion.
- gemcitabine: 100 mg per square meter, given by intravenous infusion.
- calcium folinate: 400 mg per square meter, given by intravenous infusion.
- docetaxel: 75 mg per square meter, given by intravenous infusion.
- oxaliplatin: 85 mg per square meter, given by intravenous infusion.
- carboplatin: 750 mg, given by intravenous infusion.
- paclitaxel: 175 mg per square meter, given by intravenous infusion.
- fluorouracil: 2800 mg per square meter, given by intravenous infusion.
Step 3
Treatment cycles
You will receive additional infusions according to the study schedule, which repeats until the treatment is stopped for any reason.
Step 4
Disease monitoring
Periodic imaging tests will be performed to assess disease status.
The primary goal measured is progression‑free survival, which is the time from randomization until the disease gets worse or you die, as evaluated using response evaluation criteria in solid tumors, version 1.1.
Step 5
Reporting side effects
You will complete questionnaires that record any side effects you experience, using the patient‑reported outcomes version of the ctcae.
Step 6
Treatment discontinuation
Treatment will stop if the disease progresses, if side effects become unacceptable, or when the study ends.

Who can join the trial?

18 criteria

Be able to understand the study information and sign a written informed consent (a document that shows you agree to join the trial).
Have cancer that got worse or came back after at least three rounds of platinum‑based chemotherapy (a type of cancer medicine that contains a metal called platinum).
Wait at least 2 weeks after any previous cancer treatment (such as chemotherapy, immunotherapy, or targeted therapy) and be feeling well enough that any side effects are only mild (Grade 1 or less), except for hair loss or nerve tingling, before starting the study.
If you had major surgery, radiation therapy, or special brain radiation (stereotactic radiosurgery), you must have fully recovered from any problems caused by those procedures. For radiation, the treated area must not be the tumor you will be measured, and radiation must have finished at least 14 days before joining.
If you had a serious infection that needed medicines given through an IV, you must have stopped those IV antibiotics at least 7 days before starting the study.
All side effects from previous cancer treatments must be reduced to Grade 1 (mild) or less, according to the NCI CTCAE (a standard way doctors grade side effects). Ongoing hair loss, nerve tingling, or fatigue are allowed.
Your blood must show good enough bone‑marrow health: absolute neutrophil count (a type of white blood cell) ≥ 1,500 per microliter, platelet count ≥ 100,000 per microliter, and hemoglobin (the protein that carries oxygen) ≥ 8.0 g/dL (you may receive a blood transfusion if needed).
Your liver must work well: bilirubin (a waste product) ≤ 1.5 times the normal limit (or ≤ 2.0 if direct bilirubin ≤ 1.0 mg/dL), AST and ALT (liver enzymes) ≤ 2.5 times normal (or ≤ 5 times if cancer has spread to the liver), and albumin (a protein made by the liver) > 30 g/L.
Your kidneys must work well: creatinine (a waste measured in blood) ≤ 1.5 mg/dL, or if higher, a kidney clearance test showing ≥ 30 mL/min.
If you are a man or a woman who could become pregnant and have opposite‑sex sexual activity, you must agree to use the birth‑control method required by the study.
Be willing and able to follow all study rules and visits.
Be at least 18 years old when you sign the informed consent.
Have an ECOG performance status of 0, 1, or 2 (a simple scale that measures how well you can carry out daily activities, where 0 is fully active and 2 means you can walk but cannot work).
Have a life expectancy of at least 12 weeks (about 3 months) at the start of the trial.
Have a confirmed diagnosis of “cancer of unknown primary” (CUP) that is considered unfavourable, according to current medical guidelines, with one of the following types: adenocarcinoma, poorly differentiated carcinoma, or squamous cell carcinoma.
Have a recent (within the last 30 days) CT or MRI scan of the chest, abdomen, and pelvis that doctors can use to look at the cancer; a head or neck scan is only needed if doctors think the cancer might have spread to the brain.
Have at least one tumor that can be measured on a scan using the RECIST v1.1 criteria (a standard way doctors measure tumor size). If a new biopsy is taken, it must not change the ability to measure the tumor.
Provide recent test reports that confirm the CUP diagnosis, or agree to have the study’s central lab confirm the diagnosis using a tissue sample you provide.

Who cannot join the trial?

27 criteria

Having any type of cancer that is not a carcinoma of unknown primary (CUP) as listed in the ESMO CUP guidelines.
Having another active cancer (a second malignancy) within the past three years, unless that cancer has been completely treated and shows no sign of disease for at least three years (for example, non‑melanoma skin cancer, fully removed carcinoma in situ, localized prostate cancer, or early‑stage uterine cancer).
Having any other illness, mental health condition, metabolic problem (such as diabetes), abnormal physical exam finding, or lab test result that makes the study drug unsafe, could confuse the study results, or puts you at high risk for treatment problems.
Not having fully recovered (grade 2 or higher) from side effects caused by a previous treatment, except for mild nerve problems (neuropathy) or hair loss (alopecia), which are allowed.
Testing positive on a pregnancy blood test or currently breastfeeding (for women).
Being allergic or having a hypersensitivity (strong reaction) to any part of the study medication Sacituzumab govitecan, its breakdown products, or its formulation.
Having received previous treatment with topoisomerase 1 inhibitors (a class of chemotherapy drugs).
Using any other experimental (investigational) drug within 28 days or five drug half‑lives (whichever is longer) before the first dose of the study drug, or being enrolled in another clinical trial at the same time.
Being part of any CUP subgroup that usually has a good outlook, such as:
Having a single small metastatic spot or only a few metastases that could be treated locally (single‑site or oligometastatic CUP).
Women with only axillary (under‑arm) lymph node spread that looks like breast cancer (breast‑like CUP).
Women with fluid‑filled cancer spread in the abdomen that resembles ovarian cancer (ovary‑like CUP).
Squamous cell cancer involving neck lymph nodes below the clavicle (head‑and‑neck‑like CUP).
Men with hard (blastic) bone metastases that show prostate‑specific markers (prostate‑like CUP).
Colon‑type cancer markers (CK7‑, CK20+, CDX2+) suggesting colon origin (colon‑like CUP).
Kidney‑type cancer appearance (renal‑like CUP).
Having disease that could be surgically removed or treated with radiation aiming for a cure during the study period.
Having cancer spread to the brain or spinal cord (brain or spinal cord metastasis) as seen on a CT scan or MRI, unless all of the following are true: 5 or fewer brain spots, no symptoms, all spots have been completely removed or treated with precise radiation, no need for whole‑brain radiation, and a recent scan shows no remaining disease.
Having a history or current presence of leptomeningeal disease (cancer affecting the thin membranes covering the brain and spinal cord).
Having known HIV‑1 or HIV‑2 infection with a detectable amount of virus in the blood, or taking medicines that could interfere with the study drug’s metabolism (how the body processes the drug).
Having active hepatitis B or hepatitis C infection, meaning the virus is currently detectable in the blood.
Having active chronic inflammatory bowel disease (such as ulcerative colitis or Crohn’s disease) or a hole in the gastrointestinal tract (GI perforation) within the past six months.
Having serious heart problems, including:
A heart attack (myocardial infarction) or unstable chest pain (unstable angina) within the past six months.
Severe irregular heart rhythms originating from the ventricles (ventricular tachycardia or ventricular fibrillation), high‑grade heart‑block problems (AV block), or other arrhythmias that need medication (except well‑controlled atrial fibrillation).
A prolonged QT interval on an ECG (a test that measures heart electrical activity), which can increase the risk of dangerous heart rhythms.
Moderate to severe heart failure (NYHA class III or higher) or a weakened heart pumping ability (left‑ventricular ejection fraction less than 40%).

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
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Mainz, Germany
Charite Universitaetsmedizin Berlin KöR
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Berlin, Germany
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung
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Essen, Germany

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Investigated drugs

Cisplatin
is a chemotherapy drug that contains platinum. It works by damaging the DNA of cancer cells, which helps stop the cells from growing and spreading. In this study it is used as one of the standard treatment options that doctors can choose for patients whose cancer has come back after platinum‑based therapy.
Disodium folinate
is a medication that helps protect normal cells from the harmful effects of certain chemotherapy drugs. It is given together with chemotherapy to reduce side‑effects such as kidney damage. In the trial it is used alongside other standard chemotherapy drugs as part of the investigator’s choice.
Sacituzumab govitecan
(brand name Trodelvy) is a newer type of cancer treatment called an antibody‑drug conjugate. It combines an antibody that seeks out cancer cells with a chemotherapy payload that is released directly inside those cells. This study is testing sacituzumab govitecan to see if it works better than the usual chemotherapy choices for patients whose cancer of unknown primary has returned after platinum treatment.
Gemcitabine
is a chemotherapy medicine that interferes with the way cancer cells copy their DNA, slowing their growth. It is one of the standard chemotherapy options that doctors may select for patients in this trial.
Calcium folinate
(also known as leucovorin) is used to lessen side‑effects of certain chemotherapy drugs, especially those that affect folate pathways. It is given with chemotherapy to help protect healthy cells.
Docetaxel
is a chemotherapy drug that stops cancer cells from dividing by interfering with the cell’s internal skeleton. It is commonly used for many types of cancer and is included as a possible standard treatment in the study.

What is already known about the treatment

Cisplatin
This drug is given by an intravenous (IV) infusion into a vein. It is an approved chemotherapy used for many types of cancer and is listed in medical literature worldwide. It works by causing damage to the DNA of cancer cells, which stops them from growing. It belongs to the class of platinum‑based chemotherapy agents.
Disodium folinate
This medication is also given by IV infusion. It is an approved rescue drug that is used together with certain chemotherapies to protect normal cells from damage. It supplies a form of folate that helps healthy cells repair themselves. It is classified as a folate rescue agent.
Sacituzumab govitecan
The drug is prepared as a solution for infusion and is administered by IV injection. It is an approved treatment for advanced breast and bladder cancers and is being studied for other cancers. It is an antibody‑drug conjugate that attaches to a protein on cancer cells and delivers a chemotherapy payload directly into them. It is classified as an antibody‑drug conjugate targeting Trop‑2.
Gemcitabine
This medication is given by IV infusion. It is an approved chemotherapy used for cancers such as lung, pancreas, and breast. It mimics a building block of DNA, causing the cancer cells to stop making DNA and die. It belongs to the nucleoside analog class of chemotherapy drugs.
Calcium folinate
This drug is administered by IV infusion. It is an approved agent used to boost the effect of fluorouracil and to lessen its side effects. It provides a form of folate that helps normal cells process the chemotherapy more safely. It is classified as a folate rescue or chemotherapy enhancer.
Docetaxel
The medication is delivered by IV infusion. It is an approved chemotherapy for breast, lung, prostate and other cancers. It works by blocking the ability of cancer cells to divide, which leads to their death. It belongs to the taxane class of chemotherapy agents.

Investigated diseases

Cancer of Unknown Primary - Cancer of Unknown Primary is a condition where metastatic cancer is found but the original organ where it started cannot be identified. It can involve many parts of the body such as lymph nodes, liver, bone, or lungs. The disease progresses as cancer cells continue to grow and spread despite the unknown source. It is classified as a neoplasm and is considered a rare disease in clinical studies. Patients may have already received platinum‑based chemotherapy before the study. The disease can be relapsed or refractory, meaning it continues to advance after earlier treatment.