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
CompletedPhase 1, PHASE2Results postedLast updated 16 September 2025
What this trial tests
Phase 1, PHASE2 trial testing Copanlisib in Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor in 48 participants. Completed in 30 June 2025.
18 and older, any sex, with Unresectable or Metastatic Microsatellite Stable (MSS) Solid Tumor or Microsatellite Stable (MSS) Colon Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Experiencing a Dose Limiting ToxicityPrimary· 28 days
Number of participants experiencing a Dose Limiting Toxicity (DLT) in each dose level. DLT is defined as any of the following study drug-related toxicities occurring during the first cycle of study drug on study:
* Grade 4 anemia
* Grade ≥ 3 neutropenia lasting ≥ 14 days
* Grade ≥ 3 febrile neutropenia
* Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia with clinically significant bleeding
* Treatment-related ≥ grade 4 AEs, except transient hyperglycemia
* Grade ≥ 3 Pneumonitis or recurrent Grade 2 pneumonitis
* Grade ≥ 3 Nephritis
* Grade ≥ 3 elevated AST or ALT
* Grade ≥ 2 eye pain or r
Group
Value
95% CI
Phase I - Dose Finding (Dose Level 1)
0
6-month Objective Response Rate (ORR) of Patients Treated With Copanlisib and NivolumabPrimary· 6-months
The proportion of subjects with partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per RECIST 1.1, complete response is defined as disappearance of all target lesions, and partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Lesions are assessed by CT or MRI.
Group
Value
95% CI
Phase I - Dose Finding (Dose Level 1)
0
Phase II /Cohort A- PI3K Mutation
2
Phase II /Cohort B- PI3K Wild Type
0
Disease Control Rate (DCR) Status at 6 Months.Secondary· 6-months
Percentage of participants achieving stable disease (SD) or better (SD + PR + CR).
Per RECIST 1.1, complete response is defined as disappearance of all target lesions, partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, stable disease occurs when there is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least 20% increase). Lesions are assessed by CT or MRI.
Group
Value
95% CI
Phase I - Dose Finding
0
Phase II /Cohort A - PI3K Mutation
5
Phase II /Cohort B - PI3K Wild Type
3
Duration of Response (DOR)Secondary· 3 years
Number of months from the first documentation of a partial or complete response by RECIST 1.1 to date of disease progression. Responses may be documented at any time on the study, including patients responding after the 6-month evaluation used for the primary outcome.
Group
Value
95% CI
Phase II /Cohort A- PI3K Mutation
20.6
17.0 – 22.8
Phase II /Cohort B- PI3K Wild Type
13.1
13.1 – 13.1
Progression Free Survival (PFS)Secondary· 3 years
Number of months from treatment to disease progression (PD)
Group
Value
95% CI
Phase I - Dose Finding (Dose Level 1)
1.64
1.38 – NA
Phase II /Cohort A- PI3K Mutation
1.68
1.64 – NA
Phase II /Cohort B- PI3K Wild Type
1.82
1.68 – NA
Overall Survival (OS)Secondary· 3 years
Number of months from the date of first treatment until death or end of follow-up.
Group
Value
95% CI
Phase I - Dose Finding (Dose Level 1)
5.61
2.4 – NA
Phase II /Cohort A- PI3K Mutation
6.77
4.21 – 16.04
Phase II /Cohort B- PI3K Wild Type
10.26
4.8 – NA
Number of Participants Experiencing Study Drug-related ToxicitiesSecondary· 51 months
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0.
Group
Value
95% CI
Phase I - Dose Finding (Dose Level 1)
5
Phase II /Cohort A- PI3K Mutation
16
Phase II /Cohort B- PI3K Wild Type
10
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 51 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase I - Dose Finding (Dose Level 1)
Serious: 3/6 (50%)
Deaths: 6/6
Phase II /Cohort A - PI3K Mutation
Serious: 11/21 (52%)
Deaths: 14/21
Phase II /Cohort B - PI3K Wild Type
Serious: 6/12 (50%)
Deaths: 9/12
Serious adverse events (26 terms)
Reaction
System
Phase I - Dose Finding (Do…
Phase II /Cohort A - PI3K …
Phase II /Cohort B - PI3K …
Disease progression
General disorders
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Colitis
Gastrointestinal disorders
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Abdominal pain
Gastrointestinal disorders
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Fever
General disorders
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Chylous ascites
Gastrointestinal disorders
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Colonic obstruction
Gastrointestinal disorders
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Colonic perforation
Gastrointestinal disorders
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Diarrhea
Gastrointestinal disorders
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Nausea
Gastrointestinal disorders
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Upper gastrointestinal hemorrhage
Gastrointestinal disorders
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Vomiting
Gastrointestinal disorders
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Hepatic failure
Hepatobiliary disorders
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Hip fracture
Injury, poisoning and procedural complications
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Hyperglycemia
Metabolism and nutrition disorders
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Hypokalemia
Metabolism and nutrition disorders
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Back pain
Musculoskeletal and connective tissue disorders
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Pain in extremity
Musculoskeletal and connective tissue disorders
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Chylothorax
Respiratory, thoracic and mediastinal disorders
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Dyspnea
Respiratory, thoracic and mediastinal disorders
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Rash maculopapular
Skin and subcutaneous tissue disorders
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Thromboembolic event
Vascular disorders
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Oral Mucositis
Gastrointestinal disorders
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Vocal Cord Paralysis
Respiratory, thoracic and mediastinal disorders
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Sepsis
Infections and infestations
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Respiratory Failure
Respiratory, thoracic and mediastinal disorders
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Other adverse events (114 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05082025 — Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K
· Phase 2
· terminated
NCT04933617 — Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas
· Phase 1
· terminated
NCT05010096 — BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors
· Phase 1
· withdrawn
NCT04750941 — Study of Copanlisib and Ketogenic Diet
· Phase 2
· terminated
NCT04572763 — Copanlisib Plus Venetoclax in R/R DLBCL
· Phase 1, PHASE2
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03711058.