A Phase 2 interventional study of Trilaciclib and Gemcitabine in Urothelial Carcinoma, Bladder Cancer and Myelosuppression Adult, sponsored by G1 Therapeutics, Inc.. Terminated at 34 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by G1 Therapeutics, Inc. (part of Pharmacosmos A/S) · Phase 2, Interventional, and Treatment
Among 361 studies in Carcinoma, Transitional Cell with a site in United States — 77 open to participants now, 139 under way, 14 of them phase 3. Carcinoma, Transitional Cell · United States.
Among the 361 studies in Carcinoma, Transitional Cell with a site in United States, this one is the 115th largest by enrollment of the 334 interventional ones that give a count, is one of 29 that started in 2021, is one of 110 in phase 2, and was the 241st registered.
633 studies on the registry are indexed under Carcinoma, Transitional Cell; 180 are open to participants now.
Browse Carcinoma, Transitional Cell studies →77 of the 361 studies in Carcinoma, Transitional Cell with a site in United States are open now. Recruiting first, the newest first:
Sutro Biopharma, Inc. · Sites in United States
Ages 18+
Fox Chase Cancer Center · Sites in United States
Ages 18+
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
Summit Therapeutics · Sites in United States
Ages 18+
Arvinas Inc. · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 147 Carcinoma, Transitional Cell studies recruiting now, 121 (82%) set no upper age limit and 11 (7%) stop at 75 or younger; 4 take children under 18; 8 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
361 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 175 · Phase 2 178 · Phase 3 32
First in 1994; this study’s year is marked. 29 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 92 is above the median of 50 across 500 interventional studies indexed under Carcinoma, Transitional Cell.
Median enrollment 46 across the 334 interventional studies, 285 across the 24 observational. Of the 203 that completed or were terminated, 107 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
200 of 361 have an industry lead sponsor. The 10 most frequent:
This study is registered under G1 Therapeutics, Inc., one of the names counted as Pharmacosmos A/S. Under that name alone:
G1 Therapeutics, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
Pharmacosmos A/S has 1 study filed under Carcinoma, Transitional Cell — fewer than ten, so there is no comparison to draw.
54 of the studies in Carcinoma, Transitional Cell with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06111235Phase 3CG Oncology, Inc.A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT | 2026-11 |
| NCT03815643Phase 3EMD Serono Research & Development Institute, Inc.Avelumab Program Rollover Study | 2026-11-24 |
| NCT05911295Phase 3Seagen, a wholly owned subsidiary of PfizerDisitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 | 2027-01-29 |
| NCT06774131Phase 3UroGen Pharma Ltd.A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer | 2027-03 |
| NCT05544552Tyra Biosciences, IncSafety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations | 2026-11 |
Add all 54 to your calendar (.ics) → With an account.
Among the 361 studies in Carcinoma, Transitional Cell with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in participants receiving first-line treatment for advanced/metastatic urothelial carcinoma.
Participants will be randomly assigned (1:1) to receive standard of care platinum-based chemotherapy (with or without the addition of trilaciclib) administered intravenously (IV) in 21-day cycles followed by standard of care avelumab maintenance therapy (with or without the addition of trilaciclib) administered IV in 14-day cycles.
Participants enrolled in the study will be eligible to receive 4-6 cycles of platinum-based chemotherapy, and participants without progressive disease (PD) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines (i.e., with an ongoing complete response [CR], partial response [PR], or stable disease [SD]) after platinum-based chemotherapy will be eligible to receive avelumab maintenance therapy until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the trial, whichever comes first.
Participants will be followed for survival approximately every 3 months after receiving the last dose of study medication.
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.
documented, locally advanced (T4b, any N; or any T, N 2-3) or urothelial carcinoma (M1, Stage IV) (also termed Transitional cell carcinoma [TCC] or Urothelial cell carcinoma [UCC] of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
as defined by v1.1
a. Previously irradiated lesions should not be counted as target lesions unless there has been demonstrated progression in the lesion since radiotherapy and no other lesions are available for selection as target lesions.
No prior systemic therapy in the inoperable, locally advanced, or metastatic setting including chemotherapy, therapy, targeted therapy, or agents
A formalin-fixed paraffin-embedded (FFPE) tumor tissue block (75-micron) or at least 15 (5-micron) unstained slides from archival or fresh tumor or resection; the most recent biopsy tissue preferred. Participants who have fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with the Medical Monitor.
Adequate organ function as demonstrated by the following laboratory values:
Resolution of nonhematologic toxicities from prior systemic therapy, radiation therapy, or surgical procedures to ≤ Grade 1
a. Alopecia and sensory neuropathy ≤ Grade 2, as well as any electrolyte laboratory abnormalities not constituting a safety risk based on investigator's judgment are acceptable
Exclusion Criteria:
Known history of serious, chronic active infection (e.g., , or C, tuberculosis, etc.)
a. Viral load indicative of HIV, HIV 1/2 antibodies, positive hepatitis B virus surface antigen or virus ribonucleic acid (RNA) if anti-hepatitis C virus antibody screening test positive
Severe infections within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Pregnant or lactating women
a. Women of must have negative serum pregnancy test result within 7 days prior to initiating study treatment
Received a live, attenuated vaccine within 4 weeks prior to the first dose of study drugs
History of immune colitis, inflammatory bowel disease, idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
a. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Current use of immunosuppressive medication, EXCEPT for the following:
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.
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.
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.
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.
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 protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
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.
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
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.
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.
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.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gemcitabine 1000 milligram per square meter (mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (Area under the concentration-time curve \[AUC\] 4.5) followed by Avelumab (800 mg)
Drug: Gemcitabine · Drug: Cisplatin · Drug: Carboplatin · Drug: Avelumab
Trilaciclib (240 mg/m\^2) + Gemcitabine (1000 mg/m\^2) + Cisplatin (70 mg/m\^2) or Carboplatin (AUC 4.5) followed by Trilaciclib (240 mg/m\^2) + Avelumab (800 mg)
Drug: Trilaciclib · Drug: Gemcitabine · Drug: Cisplatin · Drug: Carboplatin · Drug: Avelumab
Trilaciclib administered IV prior to chemotherapy and avelumab maintenance therapy on each day chemotherapy and avelumab maintenance therapy is administered.
Also known as: Cosela, G1T28
Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle
Cisplatin administered IV on Day 1 of each 21-day cycle
Carboplatin administered IV on Day 1 of each 21-day cycle
Avelumab administered IV on Day 1 of each 14-day maintenance cycle
Also known as: Bavencio
Number of Participants With Progression-Free Survival (PFS) During Overall Study
The PFS was defined as the time from date of randomization to the date of the first documented disease progression, or death in the absence of PD for those who had a PFS event, and the time from randomization to the censoring date for those who did not have a PFS event.
Time frame: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks
Number of Participants With Objective Response Rate (ORR) During Chemotherapy Period
The ORR defined as the percentage of participants who had an objective response (unconfirmed or confirmed) per RECIST v1.1
Time frame: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks
Number of Participants With Objective Response Rate During Overall Treatment Period
The ORR defined as the percentage of participants who had an objective response (unconfirmed or confirmed) per RECIST v1.1
Time frame: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks
Percentage of Participants Survived at 12 Months [Overall Survival (OS) Rate]
The OS during the study was defined as the time from the date of randomization to the date of death for participants who died in the study regardless of cause, or to the last contact date known to be alive for those who survived as of the date of data snapshot for intermediate planned analysis or final database lock for final analyses (censored cases).
Time frame: From date of randomization (Day 1) up to Month 12
Myeloprotective Effects
To assess the effects of trilaciclib on the neutrophil lineage as measured by the occurrence of severe neutropenia during platinum-based chemotherapy treatment. Myeloprotective effects protect the blood-forming cells in the bone marrow from the side effects of chemotherapy such as bone marrow suppression.
Time frame: Cycle 1 Day 1 (each cycle is 21 days) through treatment with platinum-based chemotherapy, approximately up to 4 months
Disease Control Rate (DCR) During Maintenance Period
The DCR was defined as the percentage of participants with best overall response (BOR) of confirmed CR, confirmed PR, or SD.
Time frame: From date of randomization, up to 12 cycles (21-day each) of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the participant or investigator, assessed up to 34 weeks.
Disease Control Rate During Overall Study
The DCR was defined as the percentage of participants with BOR of confirmed CR, confirmed PR, or SD.
Time frame: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks
Duration of Response (DoR), Overall Study
The DoR was defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first.
Time frame: From date of randomization until date of documented radiologic disease progression per RECIST v1.1 or death due to any cause, whichever comes first. Approximately 96 weeks
Number of Participants With Progression-Free Survival During Maintenance Period
The PFS was defined as the time from date of randomization to the date of the first documented disease progression, or death in the absence of PD for those who had a PFS event, and the time from randomization to the censoring date for those who did not have a PFS event.
Time frame: From date of randomization, up to 12 cycles (21-day each) of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the participant or investigator, assessed up to 34 weeks.
Percentage of Participants With Probability of Survival at 16 Months.
The OS was defined as the time from the date of randomization to the date of death for participants who died in the study regardless of cause, or to the last contact date known to be alive for those who survived as of the date for final database lock (censored cases).
Time frame: 16 months
Overall Survival During Maintenance Period
The OS was calculated as the time (months) from date of randomization to the date of death due to any cause.
Time frame: From date of randomization, up to 12 cycles (21-day each) of Maintenance therapy until disease progression, unacceptable toxicity or discontinuation by the participant or investigator, assessed up to 34 weeks.
Overall Survival During Overall Study
The OS was calculated as the time (months) from date of randomization to the date of death due to any cause.
Time frame: From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks.
Number of Participants With Adverse Events (AE)
An AE was defined as any untoward or unfavourable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
Time frame: From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks.
Number of Participants With Serious Adverse Events (SAE)
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect.
Time frame: From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks.
This study was conducted at 55 sites in the United States (US), Hungary, Georgia, France, and Spain from 4 June 2021 (first participant enrolled) to 1 March 2024 (last participant last visit).
| Milestone | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Started | 47 | 45 |
| Completed | 0 | 0 |
| Not completed | 47 | 45 |
| Withdrew: Death | 26 | 26 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Study terminated by sponsor | 18 | 17 |
| Withdrew: Other | 1 | 0 |
The PFS was defined as the time from date of randomization to the date of the first documented disease progression, or death in the absence of PD for those who had a PFS event, and the time from randomization to the censoring date for those who did not have a PFS event.
| Participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Number of Participants With Progression-Free Survival (PFS) During Overall Study | 36 | 34 |
The ORR defined as the percentage of participants who had an objective response (unconfirmed or confirmed) per RECIST v1.1
| Participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Number of Participants With Objective Response Rate (ORR) During Chemotherapy Period | 24 | 19 |
The ORR defined as the percentage of participants who had an objective response (unconfirmed or confirmed) per RECIST v1.1
| Participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Number of Participants With Objective Response Rate During Overall Treatment Period | 24 | 23 |
The OS during the study was defined as the time from the date of randomization to the date of death for participants who died in the study regardless of cause, or to the last contact date known to be alive for those who survived as of the date of data snapshot for intermediate planned analysis or final database lock for final analyses (censored cases).
| Percentage Of - Participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Percentage of Participants Survived at 12 Months [Overall Survival (OS) Rate] | 64.6 | 54.0 |
To assess the effects of trilaciclib on the neutrophil lineage as measured by the occurrence of severe neutropenia during platinum-based chemotherapy treatment. Myeloprotective effects protect the blood-forming cells in the bone marrow from the side effects of chemotherapy such as bone marrow suppression.
| Duration of severe neutropenia (days) | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Myeloprotective Effects | 0.8 ± 2.88 | 0.5 ± 2.00 |
The DCR was defined as the percentage of participants with best overall response (BOR) of confirmed CR, confirmed PR, or SD.
| Percentage of participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Disease Control Rate (DCR) During Maintenance Period | 44.8 (26.4 to 64.3) | 26.7 (12.3 to 45.9) |
The DCR was defined as the percentage of participants with BOR of confirmed CR, confirmed PR, or SD.
| percentage of participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Disease Control Rate During Overall Study | 89.1 (76.4 to 96.4) | 82.2 (67.9 to 92.0) |
The DoR was defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first.
| Months | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Duration of Response (DoR), Overall Study | 6.6 (3.3 to 8.3) | 7.0 (4.7 to 15.6) |
The PFS was defined as the time from date of randomization to the date of the first documented disease progression, or death in the absence of PD for those who had a PFS event, and the time from randomization to the censoring date for those who did not have a PFS event.
| Participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Number of Participants With Progression-Free Survival During Maintenance Period | 22 | 20 |
The OS was defined as the time from the date of randomization to the date of death for participants who died in the study regardless of cause, or to the last contact date known to be alive for those who survived as of the date for final database lock (censored cases).
| percentage of participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Percentage of Participants With Probability of Survival at 16 Months. | 44.5 (29.8 to 58.2) | 46.9 (31.5 to 60.8) |
The OS was calculated as the time (months) from date of randomization to the date of death due to any cause.
| Participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Overall Survival During Maintenance Period | 13 | 17 |
The OS was calculated as the time (months) from date of randomization to the date of death due to any cause.
| months | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Overall Survival During Overall Study | 14.6 (10.5 to NA) | 15.4 (10.2 to NA) |
An AE was defined as any untoward or unfavourable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
| Participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Number of Participants With Adverse Events (AE) | 45 | 44 |
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect.
| Participants | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAE) | 13 | 18 |
Collected over From first administration of study treatment (Day 1) until 30 days after the last dose of study treatment, approximately 96 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | 26/47 (55.3%) | 13/47 (27.7%) | 45/47 (95.7%) |
| Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | 26/45 (57.8%) | 18/45 (40%) | 44/45 (97.8%) |
| Event | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| Acute kidney injuryRenal and urinary disorders | 0/47 | 3/45 |
| Septic ShockInfections and infestations | 1/47 | 3/45 |
| Urinary tract infectionInfections and infestations | 1/47 | 3/45 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/47 | 2/45 |
| Pyelonephritis acuteInfections and infestations | 0/47 | 2/45 |
| UrosepsisInfections and infestations | 1/47 | 2/45 |
| HaematuriaRenal and urinary disorders | 2/47 | 1/45 |
| Confusional statePsychiatric disorders | 2/47 | 0/45 |
| AstheniaGeneral disorders | 1/47 | 1/45 |
| SepsisInfections and infestations | 1/47 | 1/45 |
| Event | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 28/47 | 25/45 |
| NauseaGastrointestinal disorders | 18/47 | 22/45 |
| NeutropeniaBlood and lymphatic system disorders | 16/47 | 13/45 |
| Decreased appetiteMetabolism and nutrition disorders | 9/47 | 14/45 |
| AstheniaGeneral disorders | 13/47 | 13/45 |
| ConstipationGastrointestinal disorders | 13/47 | 7/45 |
| FatigueGeneral disorders | 10/47 | 10/45 |
| ThrombocytopeniaBlood and lymphatic system disorders | 10/47 | 8/45 |
| Platelet count decreasedInvestigations | 10/47 | 4/45 |
| Neutrophil count decreasedInvestigations | 9/47 | 4/45 |
| Age, Categorical(Participants) | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 17 | 30 |
| >=65 years | 34 | 28 | 62 |
| Age, Continuous(years) | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Total |
|---|---|---|---|
| Mean | 67.8 ± 10.34 | 67.3 ± 8.40 | 67.6 ± 9.39 |
| Sex: Female, Male(Participants) | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Total |
|---|---|---|---|
| Female | 8 | 11 | 19 |
| Male | 39 | 34 | 73 |
| Ethnicity (NIH/OMB)(Participants) | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 38 | 34 | 72 |
| Unknown or Not Reported | 8 | 9 | 17 |
| Race (NIH/OMB)(Participants) | Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Trilaciclib Plus Platinum-based Chemotherapy Followed by Avelumab Maintenance Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 37 | 34 | 71 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 9 | 11 | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2021 to primary completion in Apr 2023, 22 months.
Results were first posted in Aug 2025, 2 years 4 months after primary completion.
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Studies of the drug tested here: Trilaciclib
Carcinoma, Transitional Cell →