All Trials

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic HR+/HER2− (including HER-low) breast cancer harboring an activating PIK3CA mutation, with measurable disease or evaluable bone-only disease and no prior systemic therapy for advanced disease (including endocrine-sensitive or endocrine-resistant relapse strata; ovarian/GnRH suppression required when applicable). Randomized double-blind comparison of oral LY4064809 (STX-478/tersolisib), a mutant-selective allosteric PI3Kα inhibitor, plus palbociclib and investigator-choice endocrine therapy (AI or fulvestrant) versus placebo with the same backbone, continued until progression or toxicity.

ClinicalTrials.gov ID: NCT07174336

A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults (women or men) with ER+, HER2− unresectable locally advanced or metastatic breast cancer who are systemic-therapy naïve for advanced disease (de novo or recurrence >12 months after adjuvant endocrine therapy; ECOG 0–1; measurable or bone-only disease; premenopausal women/men require GnRH suppression) are randomized to palazestrant (OP-1250; oral complete ER antagonist/next-generation SERD that promotes ER degradation, including in ESR1-mutant tumors) plus ribociclib versus standard letrozole plus ribociclib in the first-line setting.

ClinicalTrials.gov ID: NCT07085767

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with PD-L1 CPS ≥1 persistent/recurrent or newly metastatic cervical squamous/adenocarcinoma/adenosquamous carcinoma (ECOG 0–1) who complete standard first-line induction pembrolizumab + paclitaxel + platinum (with optional bevacizumab) without progression are randomized in maintenance to sacituzumab tirumotecan (MK-2870; TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload) plus pembrolizumab versus pembrolizumab alone, with bevacizumab allowed in either arm. The study tests whether adding MK-2870 improves PFS and OS and further characterizes safety/tolerability of the combination.

ClinicalTrials.gov ID: NCT07216703

AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Enrolls adults with previously untreated metastatic (stage IV) colorectal adenocarcinoma, ECOG 0–1, RECIST-measurable disease, adequate organ function, excluding MSI-high/dMMR or BRAF V600E tumors and patients with active symptomatic CNS metastases, significant bleeding/cardiovascular risk, or active autoimmune disease requiring systemic therapy. Compares PF-08634404 (SSGJ-707), a bispecific antibody targeting PD-1 and VEGF, plus standard first-line IV chemotherapy versus bevacizumab (anti-VEGF) plus the same chemotherapy, treating until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07222800

ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with previously untreated, unresectable or metastatic colorectal adenocarcinoma with measurable disease that is MSS/pMMR and without known BRAF V600E are randomized (blinded) to first-line doublet chemotherapy (FOLFOX/FOLFIRI ± CAPOX) plus pumitamig (BNT327/PM8002), a bispecific anti–PD-L1/anti–VEGF-A antibody, versus the same chemotherapy plus bevacizumab. Primary efficacy focuses on objective response in the dose-selection portion and progression-free survival by blinded central review in the confirmatory portion.

ClinicalTrials.gov ID: NCT07221357

A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo® in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Enrolling adults with previously untreated, locally advanced unresectable or metastatic colorectal cancer that is non–MSI-H/dMMR and centrally confirmed PD-L1–positive (ECOG 0–1; excludes BRAF V600E and prior checkpoint inhibitor use). Patients are randomized to mFOLFOX6 plus bevacizumab alone or the same backbone plus nivolumab with oral ONO-4578 (two dose levels), a prostaglandin E2 EP4 (PTGER4) receptor antagonist intended to reduce PGE2-driven tumor immunosuppression and enhance PD-1 blockade.

ClinicalTrials.gov ID: NCT06948448

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with previously untreated metastatic colorectal cancer (ECOG 0–1) with at least one measurable noncerebral lesion are randomized, excluding MSI-H/dMMR tumors and known BRAF V600E mutation. Patients receive ivonescimab (AK112; bispecific anti–PD-1/anti-VEGF antibody) plus mFOLFOX6 every 2 weeks for up to 8 cycles followed by ivonescimab + 5-FU/leucovorin maintenance, versus bevacizumab plus mFOLFOX6 followed by bevacizumab + 5-FU/leucovorin maintenance (up to 2 years).

ClinicalTrials.gov ID: NCT07228832

Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with previously untreated unresectable locally advanced or metastatic biliary tract adenocarcinoma (intra/extrahepatic cholangiocarcinoma or gallbladder carcinoma), ECOG 0–1, measurable disease, and centrally assessed PD-L1 status (primary analysis in PD-L1 ≥1%). Patients are randomized to gemcitabine/cisplatin plus rilvegostomig (AZD2936; bispecific anti–PD-1/TIGIT antibody with Fc modifications) versus gemcitabine/cisplatin plus durvalumab (anti–PD-L1).

ClinicalTrials.gov ID: NCT07221253

A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with stage IIIB/IIIC–IV TROP2 (NMR)-positive non-squamous NSCLC without actionable genomic alterations (EGFR/ALK/ROS1 negative and no other actionable drivers), ECOG 0–1, with RECIST-measurable progression after platinum chemotherapy and anti–PD-1/PD-L1 therapy. Randomized to datopotamab deruxtecan (TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload) IV q3w versus docetaxel IV q3w.

ClinicalTrials.gov ID: NCT07291037

Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with metastatic stage IV non-squamous NSCLC without actionable drivers, ECOG 0–1, measurable disease, who progressed on exactly one first-line regimen containing anti–PD-(L)1 therapy while still receiving it (checkpoint-inhibitor–refractory) in the 2L setting. Randomized, blinded Q3W IV comparison of visugromab (anti–GDF-15 mAb intended to reverse PD-1 resistance by restoring T-cell trafficking) + nivolumab with or without docetaxel versus docetaxel alone (with placebo controls).

ClinicalTrials.gov ID: NCT07246863