Evidence map›Paper›PMID 41520164›Full record

Trial reportThe oncologist2026

The quadruple immunotherapy for colorectal cancer (QuICC) trial for mismatch repair-proficient metastatic colorectal cancer.

Dara Bracken-Clarke, Danielle M Pastor, Jennifer L Marté, Renee N Donahue, James W Hodge, Lisa Cordes, Charalampos S Floudas, Nicholas P Tschernia, Fatima Karzai, Isaac Brownell and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04491955 (Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04491955 phase2completednot on this map

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2020 to 2024Enrolled32ConditionsSmall Bowel Cancers, Colorectal CancersArmsCV301, MSB0011359C, N-803, NHS-IL12
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Dara Bracken-ClarkeCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0002-1105-1079
Danielle M PastorCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0009-0001-5174-6019
Jennifer L MartéCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.
Renee N DonahueCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0002-6828-3073
James W HodgeCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0001-5282-3154
Lisa CordesCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0003-3833-4084
Charalampos S FloudasCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0002-0020-237X
Nicholas P TscherniaCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0002-2389-9974
Fatima KarzaiGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0002-3244-1332
Isaac BrownellCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0002-0090-9914
Evrim B TurkbeyRadiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0002-5216-3528
Patrick Soon-ShiongImmunityBio, Inc, Culver City, CA 90232, United States.ORCID 0000-0002-4682-8298
Jeffrey SchlomCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0001-7932-4072
James L GulleyCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0002-6569-2912
Hoyoung M MaengCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0002-8194-6089
Julius StraussCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0002-7550-4938
Jason M RedmanCenter for Immuno-Oncology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, United States.ORCID 0000-0001-8200-0167

Funding

Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesZIABC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2025
$22.4M
Intramural Program of the Center for Cancer Research, National Cancer InstituteNIH HHS ZIA BC 010666
6 · The paper itself

Abstract

backgroundDespite successes in other malignancies, immune checkpoint blockade (ICB) has not demonstrated reproducible efficacy in mismatch repair-proficient (pMMR) colorectal cancer (CRC). Preclinical studies indicate that multitargeted combination immunotherapy may sensitize resistant tumors to immune-mediated killing. This trial was designed to test this hypothesis by combining agents to induce and augment an immune response in pMMR CRC.

methodsIn this single-center, phase 1/2 trial, eligible patients had pMMR, RECIST v1.1-measurable metastatic CRC, ≥2 prior lines of therapy, and no prior immunotherapy. The primary endpoint was objective response rate. Patients received triplet therapy: CV-301 (CEA/MUC-1 vaccine), N-803 (IL-15 receptor superagonist), bintrafusp alfa (bifunctional anti-PD-L1/TGFβ "trap"), or quadruplet therapy (adding PDS01ADC [tumor-targeted IL-12 immunocytokine]).

resultsBetween September 2020 and September 2022, 32 patients enrolled in triplet (n = 12) and quadruplet (n = 20) therapy. The combinations had toxicity profiles consistent with each individual agent included. One complete response durable for 29+ months occurred in a patient with RAS wild-type CRC metastatic to lymph nodes who received quadruplet therapy.

conclusionQuadruplet therapy produced one objective response in unselected mCRC patients (n = 20). There were no responses with triplet therapy (n = 12). The role of ICB-based combination immunotherapy in pMMR CRC remains unclear. NCT04491955.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsDNA Mismatch RepairImmunotherapyAdultAgedFemaleHumansMaleMiddle AgedNeoplasm Metastasisantibody drug conjugatecytokine therapyimmune checkpoint inhibitorimmunotherapymetastatic colorectal cancertherapeutic cancer

Identifiers

PMID41520164
PMCPMC12932950

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.