A Phase 3 interventional study of Zanzalintinib and Pembrolizumab (+) Berahyaluronidase alfa in Colorectal Cancer, sponsored by Exelixis. Recruiting at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Exelixis · Phase 3, Interventional, and Treatment
The primary objective of this study is to evaluate the effectiveness of zanzalintinib + Pembrolizumab (+) berahyaluronidase alfa and zanzalintinib alone compared with placebo.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 600 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Exelixis is the lead sponsor of 57 studies on the registry; 11 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
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.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
Participants will receive zanzalintinib in combination with pembrolizumab (+) berahyaluronidase alfa for up to 2 years.
Drug: Zanzalintinib · Biological: Pembrolizumab (+) Berahyaluronidase alfa
Participants will receive zanzalintinib for up to 2 years.
Drug: Zanzalintinib
Participants will receive placebo to match zanzalintinib for up to 2 years.
Drug: Placebo
Oral tablets administered once daily.
Also known as: XL092
Pembrolizumab + berahyaluronidase alfa fixed-dose combination administered via subcutaneous (SC) injection once every 3 weeks (Q3W).
Also known as: KEYTRUDA QLEX™, KEYTRUDA SC, MK-3475A
Placebo to match zanzalintinib oral tablets administered once daily.
Disease-Free Survival (DFS) in Zanzalintinib + MK-3475A Versus Placebo as Assessed by the Investigator
Time frame: Up to 24 months
DFS in Zanzalintinib Monotherapy Versus Placebo as Assessed by the Investigator
Time frame: Up to 24 months
Proportion of Participants with ctDNA Clearance in Zanzalintinib + MK-3475A Versus Placebo
Time frame: Up to 24 months
Proportion of Participants with ctDNA Clearance in Zanzalintinib Monotherapy Versus Placebo
Time frame: Up to 24 months
Overall Survival (OS) in Zanzalintinib + MK-3475A Versus Placebo
Time frame: Up to 24 months
OS in Zanzalintinib Monotherapy Versus Placebo
Time frame: Up to 24 months
DFS in Zanzalintinib + MK-3475A Versus Zanzalintinib Monotherapy as Assessed by the Investigator
Time frame: Up to 24 months
Proportion of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 24 months
Plan to share: No
No publications or documents are linked to this record.
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Studies of the drug tested here: Zanzalintinib