Trial · NCT02807844

Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

NCT02807844, Phase 1, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-08-11

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies. Trials, record NCT02807844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02807844

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase Ib/II Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies
NCT number: NCT02807844
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 141 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Triple Negative Breast Cancer, Pancreatic Carcinoma, Melanoma, Endometrial Carcinoma
Interventions: MCS110, PDR001
First posted: 2016-06-21
Last updated: 2021-08-11
Other registries' IDs: eudract:2016-000210-29
Results first posted: 2021-08-11

Source ClinicalTrials.gov

Registered outcomes41

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	From start of treatment to a maximum timeframe of 116.4 weeks for phase Ib	Phase Ib: To characterize the safety and tolerability of MCS110 in combination with PDR001 in patients with advanced solid malignancies and to identify a recommended dose combination for Phase II.
Primary	Phase II : Overall Response Rate (ORR) - Per RECIST v1.1	4 years	Overall Response Rate (ORR) is defined as the proportion of patients with a best overall response assessed by CT scan or MRI of complete response (CR), disappearance of all measurable and non-measurable lesions or partial response (PR), at least a 30% decrease in the sum of diameter of all measurable lesions, taking as reference the baseline sum of diameters,. based on local Investigator assessment, as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)
Primary	Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean	4 years	Overall Response Rate (ORR) is defined as the proportion of patients with a best overall response assessed by CT scan or MRI of complete response (CR), disappearance of all measurable and non-measurable lesions or partial response (PR), at least a 30% decrease in the sum of diameter of all measurable lesions, taking as reference the baseline sum of diameters,. based on local Investigator assessment, as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) - mean (FAS)
Primary	Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1	4 years	Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) \> 4 month)) per investigator based on Response evaluation criteria in solid tumors (RECIST) v1.1
Primary	Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean	4 years	Phase II: Clinical Benefit Rate (Complete response (CR) or Partial response (PR) or Stable disease (SD) \> 4 month)) per investigator based on Response evaluation criteria in solid tumors (RECIST) v1.1
Primary	Phase Ib: Planned Dose Intensity - MCS110	Measured up to a max of 112.4 weeks	To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Planned dose intensity for MCS110 is cumulative planned dose (mg/kg)/ number of doses scheduled per protocol during treatment period (i.e., this is equivalent to planned dose level).
Primary	Phase Ib: Relative Dose Intensity - MCS110	Measured up to a max of 112.4 weeks	To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Relative dose intensity (%) is 100 × dose intensity (mg/kg/3wks)/planned dose intensity (mg/kg/3wks).
Primary	Phase Ib: Planned Dose Intensity - PDR001	Measured up to a max of 112.4 weeks	To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Planned dose intensity for PDR001 (mg/3wks) is planned cumulative dose (mg)/ number of doses scheduled per protocol during treatment period (i.e., this is equivalent to planned dose level).
Primary	Phase Ib: Relative Dose Intensity - PDR001	Measured up to a max of 112.4 weeks	To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II. Relative dose intensity (%) is 100 × dose intensity (mg/3wks)/planned dose intensity (mg/3wks).
Primary	Phase Ib: Number of Participants With Dose Reductions	Measured up to a max of 112.4 weeks	To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.

1 to 10 of 41Source ClinicalTrials.gov

See all 41 registered outcomes

Outcomes41

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	From start of treatment to a maximum timeframe of 116.4 weeks for phase Ib	Safety Analysis Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Phase II : Overall Response Rate (ORR) - Per RECIST v1.1	4 years	Full Analysis Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.	Percentage of participants	NUMBER
PRIMARY	Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean	4 years	Full Analysis Set. Since objective responses are rare in advanced pancreatic cancer and that long lasting stable disease is considered beneficial to patients, clinical benefit rate (confirmed objective response or SD\>4 months) was used as the primary endpoint for antitumor activity in this study changed from objective response to for this patient population.	Percentage of participants	MEAN
PRIMARY	Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1	4 years	Full Analysis Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.	Percentage of participants	NUMBER
PRIMARY	Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean	4 years	Full Analysis Set. Since objective responses are rare in advanced pancreatic cancer and that long lasting stable disease is considered beneficial to patients, clinical benefit rate (confirmed objective response or SD\>4 months) was used as the primary endpoint for antitumor activity in this study changed from objective response to for this patient population.	Percentage of participants	MEAN
PRIMARY	Phase Ib: Planned Dose Intensity - MCS110	Measured up to a max of 112.4 weeks	Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.	mg/kg/3wks	MEAN
PRIMARY	Phase Ib: Relative Dose Intensity - MCS110	Measured up to a max of 112.4 weeks	Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.	Percentage	MEAN
PRIMARY	Phase Ib: Planned Dose Intensity - PDR001	Measured up to a max of 112.4 weeks	Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.	mg/3wks	MEAN
PRIMARY	Phase Ib: Relative Dose Intensity - PDR001	Measured up to a max of 112.4 weeks	Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.	Percentage	MEAN
PRIMARY	Phase Ib: Number of Participants With Dose Reductions	Measured up to a max of 112.4 weeks	Safety Set. A statistical analysis for this endpoint was not performed since it is not clinically relevant.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 41Source ClinicalTrials.gov

See all 41 outcomes

Results by group868

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W	Adverse events (AEs) - all grades	6	Participants
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Adverse events (AEs) - all grades	12	Participants
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Adverse events (AEs) - all grades	12	Participants
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Adverse events (AEs) - all grades	13	Participants
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	Adverse events (AEs) - all grades	6	Participants
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	Adverse events (AEs) - all grades	11	Participants
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W	Adverse events - Treatment-related - all grades	6	Participants
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	Adverse events - Treatment-related - all grades	12	Participants
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	Adverse events - Treatment-related - all grades	11	Participants
Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	Adverse events - Treatment-related - all grades	8	Participants

1 to 10 of 868Source ClinicalTrials.gov

See all 868 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W	6
Overall Study	STARTED	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W	12
Overall Study	STARTED	Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W	12
Overall Study	STARTED	Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W	13
Overall Study	STARTED	Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W	6
Overall Study	STARTED	Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W	11
Overall Study	STARTED	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC	20
Overall Study	STARTED	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC	20
Overall Study	STARTED	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC	21
Overall Study	STARTED	Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME	20

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events2,560

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Ph Ib: MCS110@1 mg/kg Q3W@+ PDR001 100@mg Q3W	4	6
other	Anaemia	Blood and lymphatic system disorders	Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 100@mg Q3W	2	12
other	Anaemia	Blood and lymphatic system disorders	Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 300@mg Q3W	3	12
other	Anaemia	Blood and lymphatic system disorders	Ph Ib: MCS110@5 mg/kg Q3W@+ PDR001 300@mg Q3W	3	13
other	Anaemia	Blood and lymphatic system disorders	Ph Ib: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W	3	6
other	Anaemia	Blood and lymphatic system disorders	Ph Ib: MCS110@10 mg/kg Q3W@+ PDR001 300@mg Q3W	3	11
other	Anaemia	Blood and lymphatic system disorders	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - TNBC	4	20
other	Anaemia	Blood and lymphatic system disorders	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - PC	6	20
other	Anaemia	Blood and lymphatic system disorders	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - EC	5	21
other	Anaemia	Blood and lymphatic system disorders	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - ME	7	20

1 to 10 of 2,560Source ClinicalTrials.gov

See all 2,560 adverse events

Adverse event totals30

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ph Ib: MCS110@1 mg/kg Q3W@+ PDR001 100@mg Q3W	0	6
Total, all-cause mortality	Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 100@mg Q3W	1	12
Total, all-cause mortality	Ph Ib: MCS110@3 mg/kg Q3W@+ PDR001 300@mg Q3W	4	12
Total, all-cause mortality	Ph Ib: MCS110@5 mg/kg Q3W@+ PDR001 300@mg Q3W	4	13
Total, all-cause mortality	Ph Ib: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W	1	6
Total, all-cause mortality	Ph Ib: MCS110@10 mg/kg Q3W@+ PDR001 300@mg Q3W	4	11
Total, all-cause mortality	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - TNBC	1	20
Total, all-cause mortality	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - PC	3	20
Total, all-cause mortality	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - EC	0	21
Total, all-cause mortality	Ph II: MCS110@7.5 mg/kg Q3W@+ PDR001 300@mg Q3W - ME	2	20

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38721402	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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API reference For AI assistants