NCT02807844

Brief Summary

The purpose of this study of MCS110 with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_1

Geographic Reach
11 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

June 29, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 11, 2021

Completed
Last Updated

August 11, 2021

Status Verified

July 1, 2021

Enrollment Period

3.9 years

First QC Date

June 17, 2016

Results QC Date

May 25, 2021

Last Update Submit

July 12, 2021

Conditions

Triple Negative Breast CancerPancreatic CarcinomaMelanomaEndometrial Carcinoma

Keywords

Triple negative breast cancerPancreatic carcinomaMelanomaEndometrial CarcinomaImmuno oncologyMonoclonal antibodyPDR001MCS110Advanced malignanciesmetastesesadvanced cancermalignant

Outcome Measures

Primary Outcomes (13)

  • Phase Ib: Percentage of Participants With Adverse Events, as a Measure of Safety

    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.

    From start of treatment to a maximum timeframe of 116.4 weeks for phase Ib

  • Phase II : Overall Response Rate (ORR) - Per RECIST v1.1

    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)

    4 years

  • Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per RECIST v1.1 - Mean

    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)

    4 years

  • Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per RECIST v1.1

    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

    4 years

  • Phase II: Bayesian Inference of Clinical Benefit Rate - Per RECIST v1.1- Mean

    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

    4 years

  • Phase Ib: Planned Dose Intensity - MCS110

    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).

    Measured up to a max of 112.4 weeks

  • Phase Ib: Relative Dose Intensity - MCS110

    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 Ă— dose intensity (mg/kg/3wks)/planned dose intensity (mg/kg/3wks).

    Measured up to a max of 112.4 weeks

  • Phase Ib: Planned Dose Intensity - PDR001

    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).

    Measured up to a max of 112.4 weeks

  • Phase Ib: Relative Dose Intensity - PDR001

    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 Ă— dose intensity (mg/3wks)/planned dose intensity (mg/3wks).

    Measured up to a max of 112.4 weeks

  • Phase Ib: Number of Participants With Dose Reductions

    To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.

    Measured up to a max of 112.4 weeks

  • Phase Ib: Number of Dose Interruptions Per Participant

    To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.

    Measured up to a max of 112.4 weeks

  • Phase Ib: Number of Subjects With at Least One Dose Interruption

    To characterize the tolerability of MCS110 given in combination with PDR001 and to identify a recommended dose combination for Phase II.

    Measured up to a max of 112.4 weeks

  • Phase Ib: Number of Participants With Dose Limiting Toxicities (DLTs) During the First 2 Cycles of Study Treatment

    Phase Ib: Dose limiting toxicities occurring during the first 2 cycles by system organ class, preferred term and maximum grade for Phase Ib. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 was used for all grading.

    the first 2 cycles of study treatment; cycle = 21 days (i.e., at day 42)

Secondary Outcomes (28)

  • Phase II : Overall Response Rate (ORR) - Per irRC

    4 years

  • Phase Ib: Overall Response Rate (ORR)

    4 years

  • Phase II : Bayesian Inference of Overall Response Rate (ORR) - Per irRC - Mean

    4 years

  • Phase 1b: Clinical Benefit Rate (CBR)

    4 years

  • Phase II: Clinical Benefit Rate (Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) > 4 Month)) - Per irRC

    4 years

  • +23 more secondary outcomes

Study Arms (10)

Ph Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3W

EXPERIMENTAL

Phase Ib: MCS110 1 mg/kg every 3 weeks (Q3W) + PDR001 100 mg Q3W

Drug: MCS110Drug: PDR001

Ph Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W

EXPERIMENTAL

Phase Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3W

Drug: MCS110Drug: PDR001

Ph Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W

EXPERIMENTAL

Phase Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3W

Drug: MCS110Drug: PDR001

Ph Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W

EXPERIMENTAL

Phase Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3W

Drug: MCS110Drug: PDR001

Ph Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W

EXPERIMENTAL

Phase Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W

Drug: MCS110Drug: PDR001

Ph Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W

EXPERIMENTAL

Phase Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3W

Drug: MCS110Drug: PDR001

Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBC

EXPERIMENTAL

Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Triple negative breast cancer (TNBC)

Drug: MCS110Drug: PDR001

Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PC

EXPERIMENTAL

Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Pancreatic cancer (PC)

Drug: MCS110Drug: PDR001

Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - EC

EXPERIMENTAL

Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Endometrial cancer (EC)

Drug: MCS110Drug: PDR001

Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ME

EXPERIMENTAL

Phase II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - Melanoma (ME)

Drug: MCS110Drug: PDR001

Interventions

MCS110DRUG

MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Also known as: colony-stimulating factor-1 [CSF-1])
Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ECPh II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - MEPh II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PCPh II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBCPh Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3WPh Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3WPh Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3WPh Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3WPh Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3WPh Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W
PDR001DRUG

MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.

Ph II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - ECPh II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - MEPh II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - PCPh II: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W - TNBCPh Ib: MCS110 1 mg/kg Q3W + PDR001 100 mg Q3WPh Ib: MCS110 10 mg/kg Q3W + PDR001 300 mg Q3WPh Ib: MCS110 3 mg/kg Q3W + PDR001 100 mg Q3WPh Ib: MCS110 3 mg/kg Q3W + PDR001 300 mg Q3WPh Ib: MCS110 5 mg/kg Q3W + PDR001 300 mg Q3WPh Ib: MCS110 7.5 mg/kg Q3W + PDR001 300 mg Q3W

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent prior to any procedures
  • Phase Ib part: Adult patients with advanced melanoma, endometrial carcinoma, pancreatic or TNBC, with measurable or non-measurable disease who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists.
  • Phase II part: Adult patients with advanced solid tumors who have received standard therapy (no more than 3 prior lines of treatment) or are intolerant of standard therapy, have progressed following their last prior therapy, and fit into one of the following groups:
  • Group 1: TNBC who did not receive prior anti-PD-1/PD-L1 treatment
  • Group 2: Pancreatic adenocarcinoma who did not receive prior anti-PD-1/PD-L1 treatment
  • Group 3: Endometrial carcinoma who did not receive prior anti-PD-1/PD-L1 treatment
  • Group 4: Melanoma who progressed on prior anti-PD-1/PD-L1 treatment.

You may not qualify if:

  • Patients with the following:
  • Symptomatic central nervous system (CNS) metastases or those requiring local CNS-directed therapy.
  • Abnormal liver, renal, or blood lab values.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Active autoimmune disease or documented autoimmune disease within 3 years of screening.
  • Active infection requiring antibiotic therapy.
  • Known HIV, active hepatitis B or C virus.
  • Concurrent malignant disease.
  • Patients who received systemic anticancer therapy, major surgery, or radiotherapy within 2 weeks of study treatment, or live vaccines within 4 weeks of study treatment.
  • Patients requiring chronic treatment with systemic steroid therapy or any immunosuppressive therapy.
  • Patients who used hematopoietic colony-stimulating growth factors within 2 weeks of study treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Dana Farber Cancer Center

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63123, United States

Location

The West Clinic

Germantown, Tennessee, 38138, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Wilrijk, 2610, Belgium

Location

Novartis Investigative Site

HUS, FIN-00029, Finland

Location

Novartis Investigative Site

Saint-Herblain, 44805, France

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Koto Ku, Tokyo, 135 8550, Japan

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Seoul, 05505, South Korea

Location

Novartis Investigative Site

Valencia, Valencia, 46010, Spain

Location

Novartis Investigative Site

Madrid, 28009, Spain

Location

Novartis Investigative Site

Chur, 7000, Switzerland

Location

Novartis Investigative Site

Geneva, CH 1211, Switzerland

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Ahmed J, Stephen B, Yang Y, Kwiatkowski E, Ejezie CL, Pant S. Phase Ib/II Study of Lacnotuzumab in Combination with Spartalizumab in Patients with Advanced Malignancies. J Immunother Precis Oncol. 2024 May 2;7(2):73-81. doi: 10.36401/JIPO-23-16. eCollection 2024 May.

    PMID: 38721402DERIVED

MeSH Terms

Conditions

Triple Negative Breast NeoplasmsPancreatic NeoplasmsMelanomaEndometrial Neoplasms

Interventions

Macrophage Colony-Stimulating Factorspartalizumab

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@Novartis.com
+ 1 862 778 8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

June 29, 2016

Primary Completion

June 4, 2020

Study Completion

June 4, 2020

Last Updated

August 11, 2021

Results First Posted

August 11, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

More information

Locations

ES(2)CH(3)FI(1)DE(2)IT(2)JP(1)US(4)KR(2)FR(1)HK(1)BE(1)