Cancer clinical trial database.
Every new trial and trial result from New in Oncology, our weekly research briefing, since the first issue on . Search by NCT number, drug, or cancer type.
All entries in colorectal cancer
- New trial Spotlight
Colorectal cancer
Phase 3 STELLAR-316 tests zanzalintinib with or without pembrolizumab for ctDNA-positive, scan-negative colorectal cancer
Exelixis’ randomized Phase 3 STELLAR-316 study enrolls resected stage II/III colon or rectal adenocarcinoma that is MSS or MSI-low/pMMR, with molecular residual disease detected by the Signatera ctDNA assay after…
NCT07750158 Registrational - New trial
Colorectal cancer
Phase 1/1b CHAMP adds CCR5 blockade with leronlimab to surgery, hepatic arterial floxuridine, and systemic therapy for colorectal liver metastases
City of Hope’s single-arm CHAMP study evaluates leronlimab, CytoDyn’s CCR5-blocking monoclonal antibody, with a liver-directed treatment program for resectable, liver-dominant colorectal cancer metastases.…
NCT07842965 Exploratory - New trial
Colorectal cancer
Phase 2 COMBAT tests botensilimab plus balstilimab for ctDNA-positive molecular residual disease in MSS colorectal cancer
This open-label Phase 2 NCI/ETCTN study evaluates botensilimab, an Fc-enhanced CTLA-4-directed antibody, with balstilimab, a PD-1-blocking antibody, in MSS stage II/III colorectal cancer with ctDNA-positive molecular…
NCT07551596 Exploratory - New trial Spotlight
Colorectal cancer
Phase 2 VVD-133214 WRN helicase covalent inhibitor + pembrolizumab (PD-1 antibody) in MSI/dMMR CRC
This randomized, open-label Phase 2 study tests whether adding VVD-133214 (RO7589831)—a first-in-class, covalent allosteric inhibitor of Werner helicase (WRN)—can improve outcomes versus pembrolizumab alone in…
NCT07811193 Exploratory - New trial
Colorectal cancer
Phase 2 porustobart CTLA-4 antibody + pembrolizumab PD-1 antibody in resectable MSS colon cancer
This Phase 2, open-label, multicenter, randomized neoadjuvant trial tests whether adding porustobart (a CTLA-4–blocking monoclonal antibody) to pembrolizumab (a PD-1–blocking monoclonal antibody from Merck/MSD) can…
NCT07808151 Exploratory - Trial result
Colorectal cancer
PEGASUS ctDNA MRD assay guides adjuvant CAPOX→FOLFIRI escalation but misses relapse-free feasibility target in resected MSS colon cancer
PEGASUS (Phase 2, multicenter, single-arm; NCT04259944) tested a postoperative circulating tumor DNA (ctDNA) minimal residual disease (MRD) strategy in resected microsatellite-stable T4N0 (high-risk stage II) and…
NCT04259944 - Trial result
Colorectal cancer
Adjuvant Chemo Shows No Clear Added Benefit After FOLFIRINOX-Based TNT in Pooled LARC Analysis
A pooled post-hoc analysis of two French randomized trials (GRECCAR 4; NCT01333709 and PRODIGE 23; NCT01804790) evaluated whether postoperative adjuvant chemotherapy (typically fluoropyrimidine/oxaliplatin-based)…
NCT01333709 - New trial Spotlight
Colorectal cancer
Phase 2 trastuzumab rezetecan (SHR-A1811) HER2-directed topoisomerase I inhibitor ADC in 1L mCRC
HORIZON-CRC221 is a global, multicenter, randomized, dose-optimization Phase 2 study testing two dose levels of trastuzumab rezetecan (SHR-A1811)—a HER2-targeted monoclonal antibody–drug conjugate delivering a…
NCT07796763 Exploratory - New trial Spotlight
Colorectal cancer
Phase 3 petosemtamab (EGFR×LGR5 bispecific antibody) vs cetuximab in 1L left-sided mCRC
Genmab’s LiGeR-CRC1 is a randomized, open-label Phase 3 trial testing whether petosemtamab (MCLA-158; an EGFR×LGR5-directed bispecific monoclonal antibody designed to block EGFR signaling and target LGR5-expressing…
NCT07702032 Registrational - New trial
Colorectal cancer
Phase 2 cemiplimab PD-1 antibody trial adds fianlimab LAG-3 and REGN7075 EGFR×CD28 bispecific.
NSABP Foundation’s EMPIRE (NSABP FC-13) is an open-label, randomized Phase 2 platform study testing whether adjuvant immunotherapy can clear ctDNA-defined minimal residual disease (MRD) and reduce recurrence after…
NCT07058012 Exploratory - Trial result
Colorectal cancer
SCRT (5×5Gy) + CAPOX Total Neoadjuvant Therapy Improves 5-Year OS vs Long-Course Capecitabine-CRT in LARC (STELLAR)
Short-course radiotherapy (SCRT; 5Gy×5) followed by consolidation chemotherapy (CAPOX) as total neoadjuvant therapy (TNT) was compared with standard long-course chemoradiotherapy (LCRT ~50Gy with concurrent…
NCT02533271 - New trial Spotlight
Colorectal cancer
Phase 2 ivonescimab PD-1×VEGF bispecific antibody plus intraperitoneal paclitaxel chemotherapy
MD Anderson Cancer Center is running this Phase 2, single-arm study testing ivonescimab (a PD-1 and VEGF-targeted bispecific antibody; developed by Akeso Biopharma and partnered by Summit Therapeutics) combined with…
NCT07753824 Exploratory - Trial result Spotlight
Colorectal cancer
Sotorasib (KRAS G12C inhibitor) + panitumumab (EGFR mAb) + FOLFIRI drives 56.5% ORR in pretreated KRAS G12C mCRC
Sotorasib is an oral covalent KRAS G12C inhibitor and panitumumab is an EGFR-targeting monoclonal antibody; here they were combined with irinotecan/leucovorin/5-FU (FOLFIRI) in the CodeBreaK 101 Phase 1b subprotocol…
NCT04185883 - New trial
Colorectal cancer
Phase 2 S-531011 CCR8-directed monoclonal antibody plus RadScopal radiation in MSS mCRC.
This Phase 2 MD Anderson Cancer Center study tests whether S-531011 (a CCR8-directed monoclonal antibody designed to modulate CCR8+ immune cells in the tumor microenvironment) can work better when paired with…
NCT07720115 Exploratory - Trial result
Colorectal cancer
mFOLFOX6/Bevacizumab + Atezolizumab (PD-L1) Extends PFS vs Atezolizumab Alone in 1L dMMR/MSI-H mCRC
NRG-GI004/SWOG S1610 (COMMIT; Phase III, open-label) randomized patients with previously untreated dMMR/MSI-H metastatic colorectal cancer to atezolizumab (PD-L1 antibody) monotherapy vs mFOLFOX6 + bevacizumab (VEGF…
- Trial result
Colorectal cancer
High-dose vitamin D3 (cholecalciferol) add-on fails to move the needle on PFS in 1L mCRC (SOLARIS)
Vitamin D3 (cholecalciferol) supplementation was tested as a non-oncologic add-on to standard first-line mCRC therapy—mFOLFOX6 or FOLFIRI plus bevacizumab—in the US-based, double-blind SOLARIS Phase 3 trial…
NCT04094688 - New trial Spotlight
Colorectal cancer
Phase 2 botensilimab CTLA-4 antibody + balstilimab PD-1 antibody in early MSS rectal cancer.
This prospective, multi-site, non-randomized Phase 2 study (RECTIFY-1) tests neoadjuvant dual-checkpoint blockade in early, resectable rectal adenocarcinoma that is microsatellite stable / mismatch repair proficient…
NCT07735624 Exploratory - Trial result
Colorectal cancer
Vactosertib (TGFBR1/ALK5 inhibitor) + pembrolizumab drives 12.6% ORR in MSS/non–MSI-high mCRC—0% in gastric cancer
Vactosertib is an oral TGF-β receptor type 1 (TGFBR1/ALK5) kinase inhibitor designed to blunt TGF-β–mediated immune exclusion, and was combined with pembrolizumab (PD-1) in a multicenter, open-label, single-arm Phase…
NCT03724851 - Trial result
Colorectal cancer
Ad5.F35-GUCY2C-PADRE (adenoviral vaccine swapping Ad35 fiber) drives CD8+ immunity and fewer CRC recurrences
Ad5.F35-GUCY2C-PADRE is a chimeric adenovirus serotype 5 vaccine expressing the intestinal tumor antigen GUCY2C (plus PADRE helper epitope) and using an Ad35 fiber to bypass pre-existing anti-Ad5 neutralizing…
NCT04111172 - Trial result
Colorectal cancer
Doublet long-course TNT (capecitabine/oxaliplatin) improves DFS and pCR vs standard nCRT in high-risk LARC
Doublet-LC TNT integrates long-course radiotherapy (LCRT) with uninterrupted doublet chemotherapy (capecitabine + oxaliplatin; induction → concurrent → consolidation) before surgery, versus conventional neoadjuvant…
NCT03177382 - Trial result Spotlight
Colorectal cancer
Toripalimab (PD-1) + celecoxib (COX-2) lifts pCR to 89% in dMMR/MSI-H locally advanced CRC (PICC-2)
Toripalimab is an anti–PD-1 monoclonal antibody, and celecoxib is an oral COX-2 inhibitor hypothesized to reshape the inflammatory tumor microenvironment to potentiate checkpoint blockade. In the open-label,…
NCT03926338 - Trial result
Colorectal cancer
CapeOx “sandwich” TNT (fluoropyrimidine/oxaliplatin + RT) drives 46.9%cCR and 46.4%pCR in low-risk distal LARC
CapeOx (capecitabine + oxaliplatin) is a fluoropyrimidine/platinum doublet used here as a “sandwich” total neoadjuvant therapy (TNT) backbone, delivered as 2 cycles before, during, and after long-course radiotherapy,…
NCT03840239 - Trial result Spotlight
Colorectal cancer
EC (encorafenib+BRAF inhibitor) + cetuximab (EGFR mAb) + FOLFIRI cuts PFS risk ~56% in 1L BRAF V600E mCRC
Encorafenib (BRAF inhibitor) plus cetuximab (EGFR antibody) was combined with FOLFIRI chemotherapy as first-line treatment in BREAKWATER Cohort 3 (Phase 3, open-label; NCT04607421) for untreated BRAF V600E–mutant…
NCT04607421 - Trial result
Colorectal cancer
ctDNA (MRD)-guided ACT (capecitabine±oxaliplatin) cuts 3-year recurrence in stage II MSS colon cancer
CIRCULATE (AIO KRK-0217/ABCSG; NCT04089631) used a tumor-informed NGS ctDNA assay post-op in stage II pMMR/MSS colon cancer: ctDNA+ patients were randomized to adjuvant chemotherapy (6 mo capecitabine or 3–6 mo…
NCT04089631 - Trial result
Colorectal cancer
Nivolumab + ipilimumab (PD-1 + CTLA-4) improves long-term treatment-free survival vs nivolumab in MSI-H/dMMR mCRC
Nivolumab + ipilimumab (NIVO + IPI), a dual immune checkpoint regimen targeting PD-1 and CTLA-4, was compared with nivolumab (PD-1) monotherapy in the Phase 3 CheckMate 8HW trial in metastatic colorectal cancer with…
NCT04008030 - New trial
Colorectal cancer
Phase 2 tovecimig DLL4×VEGF bispecific antibody plus FOLFIRI in second-line metastatic CRC.
This open-label Phase 2 investigator-sponsored study evaluates whether adding tovecimig—Compass Therapeutics’ DLL4- and VEGF-directed bispecific monoclonal antibody (dual angiogenesis / Notch-pathway modulation)—can…
NCT07662031 Exploratory - Trial result
Colorectal cancer
Avelumab (PD-L1) + neoadjuvant chemoradiotherapy delivers 74.7% 4-year PFS in high-risk LARC (AVANA)
Avelumab is an anti–PD-L1 immune checkpoint inhibitor added to standard neoadjuvant long-course chemoradiotherapy (CTRT) for locally advanced rectal cancer, aiming to deepen response before surgery. In the…
NCT03854799 - Trial result
Colorectal cancer
Toripalimab (PD-1) + CAPOX iTNT, with SCRT, lifts complete response to 61% in high-risk pMMR LARC
TORCH-iTNT (NCT06281405) is a randomized Phase 2 study in pMMR/MSS locally advanced rectal cancer (T3–4/N+M0) comparing 6 cycles of CAPOX (capecitabine/oxaliplatin) + toripalimab (PD-1 inhibitor) alone (Group A) vs…
NCT06281405 - Trial result Spotlight
Colorectal cancer
Ivonescimab (PD-1×VEGF bispecific) + mFOLFOX6 posts 70.8% ORR and 100% DCR in 1L unresectable mCRC (Phase 2)
Ivonescimab is an investigational tetrameric bispecific antibody co-targeting PD-1 and VEGF, here combined with oxaliplatin/5-FU/leucovorin (mFOLFOX6) as first-line therapy in a multiregional Phase 2 trial…
NCT05382442 - Trial result Spotlight
Colorectal cancer
Zongertinib (selective irreversible HER2 TKI) drives 45% ORR with mostly grade 1 diarrhea in HER2+ CRC
Zongertinib is an irreversible, HER2-selective tyrosine kinase inhibitor designed to spare wild-type EGFR (aiming to reduce classic EGFR-TKI rash/diarrhea) and was evaluated as monotherapy in a pooled subgroup of…
NCT04886804
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