Evidence map›Paper›PMID 42493490›Full record

Trial reportNature communications2026

Copanlisib in combination with nivolumab formicrosatellite stable colorectal cancer: a phase 1/2 trial.

Eric S Christenson, Jeremiah A Wala, Rose Parkinson, Natalie B Collins, Christopher Jakubowski, Jia-Ren Lin, Kristin Qian, Jiayun Lu, Hao Wang, Won Jin Ho and 17 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03711058 (A Phase I/II Study of PI3Kinase Inhibition), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT03711058 phase1 / phase2completednot on this map

A Phase I/II Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2019 to 2025Enrolled48ConditionsUnresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor, Microsatellite Stable (MSS) Colon CancerArmsCopanlisib, Nivolumab
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

27 authors.

Eric S Christenson *Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Jeremiah A Wala *Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
Rose ParkinsonDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Natalie B CollinsHarvard Ludwig Center and Harvard Medical School, Boston, MA, USA.ORCID 0000-0003-2980-9244
Christopher JakubowskiDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0002-1085-2157
Jia-Ren LinHarvard Ludwig Center and Harvard Medical School, Boston, MA, USA.ORCID 0000-0003-4702-7705
Kristin QianHarvard Ludwig Center and Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-5016-0112
Jiayun LuDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Hao WangDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0001-6489-6940
Won Jin HoDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0003-2644-5086
Sabrina ChanDepartment of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
Ewa KulikowiczDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Rachel KleinDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Yvette CetasaanDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Emma JohnsonDepartment of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
Maureen BergDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Jeffrey A MeyerhardtDepartment of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
Dung T LeDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0002-2110-7697
Benjamin L SchlechterDepartment of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-1529-3278
Ilene BrownerDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Lei ZhengDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0003-4163-2541
Harshabad SinghDepartment of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.ORCID 0000-0001-6295-2013
Ross DonehowerDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Elizabeth M JaffeeDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0003-3841-6549
Peter K SorgerHarvard Ludwig Center and Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-3364-1838
Marios Giannakis *Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.ORCID 0000-0001-9012-6982
Nilofer Azad *Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine, Baltimore, MD, USA. nilo.azad@jhmi.edu.

Funding

Tumor Antigens for Individual Signatures and TherapyP50CA062924 · NCI · JOHNS HOPKINS UNIVERSITY · PI THOMPSON, ELIZABETH D · 1993 to 2022
$54.6M
Dissecting the impact of tumor-immune spatial interactions in mismatch-repair stratified colorectal cancersK99CA300495 · NCI · DANA-FARBER CANCER INST · PI Jeremiah Wala · 2025 to 2026
$341k
NCI NIH HHS K99 CA300495NCI NIH HHS P50 CA062924
6 · The paper itself

Abstract

PIK3CA is mutated in ~15% of colorectal cancers (CRC). PI3K regulates immunity, inhibition potentially enhances anti-tumor immunity. We launched a phase 1/2 trial of copanlisib (PIK3CA inhibitor) and nivolumab (anti-PD-1) in metastatic microsatellite stable CRC (NCT03711058): Cohort A: PIK3CAwt (n = 17) and Cohort B: PIK3CAmut (n = 22). Copanlisib/nivolumab is well tolerated with recommended phase 2 dose of nivolumab 480 mg day 1 and copanlisib 60 mg days 1/8/15 of a 28-day cycle. Primary endpoint of objective response rate at 6 months was not met with Cohort A: 0/17 and Cohort B: 2/22 having 6-month treatment response. Secondary endpoints are median progression-free survival (Cohort A: 1.7 months; Cohort B: 1.6 months), median overall survival (Cohort A: 8.5 months; Cohort B: 6.7 months), duration of response (Cohort A: 13.1 months; Cohort B: 17 months) and 6-month disease control rate (Cohort A: 2/17; Cohort B: 3/22). Secondary endpoints were not statistically different between these cohorts.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsNivolumabPyrimidinesQuinazolinesAgedClass I Phosphatidylinositol 3-KinasesFemaleHumansMaleMiddle AgedMutationProgression-Free SurvivalClass I Phosphatidylinositol 3-KinasescopanlisibNivolumabPIK3CA protein, humanPyrimidinesQuinazolines

Identifiers

PMID42493490
PMCPMC13396235

What Socratic holds

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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 Socratic graph.