NCT04311710

Brief Summary

A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2020

Typical duration for phase_1

Geographic Reach
3 countries

6 active sites

Status
terminated

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

March 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 25, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

March 16, 2020

Last Update Submit

February 23, 2023

Conditions

Tumor

Keywords

lung cancer, renal cancer, bladder cancer, skin cancer, liver cancer

Outcome Measures

Primary Outcomes (15)

  • Part 1 Arm A: Average concentration of ipilimumab (Cavg21d)

    Day 21

  • Part 1 Arm A: Area under the concentration in ipilimumab AUC(0-21d)

    Day 21

  • Part 1 Arm A: Maximum observed serum concentration of ipilimumab (Cmax)

    Up to 21 days

  • Part 1 Arm A: Observed concentration of ipilimumab at 21 days post dose (C21d)

    Day 21

  • Part 1 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)

    Up to 21 days

  • Part 2 Arm A: Average concentration in ipilimumab (Cavg42d)

    Day 42

  • Part 2 Arm A: Area under the concentration in ipilimumab AUC(0-42d)

    Day 42

  • Part 2 Arm A: Maximum observed serum Concentration of Ipilimumab (Cmax)

    Up to 42 days

  • Part 2 Arm A: Observed concentration in ipilimumab (C42d)

    Day 42

  • Part 2 Arm A: Time of maximum observed concentration in ipilimumab (Tmax)

    Up to 42 days

  • Part 2 Arm B: Average concentration of Ipilimumab at 21 days post dose (Cavg21d)

    Day 21

  • Part 2 Arm B: Area Under the Concentration in Ipilimumab AUC(0-21d)

    Day 21

  • Part 2 Arm B: Maximum observed serum Concentration in Ipilimumab (Cmax)

    Up to 21 days

  • Part 2 Arm B: Observed concentration of ipilimumab at 21 days post dose (C21d)

    Day 21

  • Part 2 Arm B: Time of maximum observed concentration in Ipilimumab (Tmax)

    Up to 21 days

Secondary Outcomes (18)

  • Part 1 Arm B: Average concentration of ipilimumab without rHuPH20 (Cavg21d)

    Day 21

  • Part 1 Arm B: Area under the concentration in ipilimumab without rHuPH20 AUC(0-21d)

    Day 21

  • Part 1 Arm B: Maximum observed serum concentration of ipilimumab without rHuPH20 (Cmax)

    Up to 21 days

  • Part 1 Arm B: Observed concentration of ipilimumab without rHuPH20 at 21 days post dose (C21d)

    Day 21

  • Part 1 Arm B: Time of maximum observed concentration in ipilimumab without rHuPH20 (Tmax)

    Up to 21 days

  • +13 more secondary outcomes

Study Arms (4)

Part 1 Arm A: mM, mUC, HCC

EXPERIMENTAL

metastatic Melanoma (mM), metastatic Urothelial Carcinoma (mUC), and advanced Heptocellular Carcinoma (HCC)

Drug: ipilimumabDrug: nivolumabDrug: ENHANZE (rHuPH20)

Part 1: Arm B: mM

EXPERIMENTAL

metastatic Melanoma (mM)

Drug: ipilimumabDrug: nivolumab

Part 2: Arm A: NSCLC

EXPERIMENTAL

metastatic non small cell lung cancer (NSCLC)

Drug: ipilimumabDrug: ENHANZE (rHuPH20)Drug: nivolumab

Part 2: Arm B: RCC

EXPERIMENTAL

advanced or metastatic renal cell carcinoma (RCC)

Drug: ipilimumabDrug: ENHANZE (rHuPH20)Drug: nivolumab

Interventions

ipilimumabDRUG

Specified Dose on Specified Days

Also known as: (BMS-734016)
Part 1 Arm A: mM, mUC, HCCPart 1: Arm B: mMPart 2: Arm A: NSCLCPart 2: Arm B: RCC
nivolumabDRUG

Specified Dose on Specified Days

Also known as: (BMS-936558)
Part 1 Arm A: mM, mUC, HCCPart 1: Arm B: mM
ENHANZE (rHuPH20)DRUG

Specified Dose on Specified Days

Part 1 Arm A: mM, mUC, HCCPart 2: Arm A: NSCLCPart 2: Arm B: RCC

Eligibility Criteria

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

You may qualify if:

  • Men and women must follow methods of contraception as described in the protocol
  • Part 1 Arms A and B: Metastatic Melanoma
  • \- Previously untreated, histologically confirmed stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system v.8.0
  • Part 1 Arm A:Advanced/mUC - Participants with histologically or cytologically confirmed urothelial carcinoma.
  • Part 1 Arm A: Advanced HCC
  • Participants with histological confirmation of Hepatocellular Cancer (HCC)
  • Part 2 Arm A: Metastatic NSCLC
  • \- Participants with histologically confirmed stage IV or recurrent Non Small Cell Lung Cancer (NSCLC)
  • Part 2 Arm B: Advanced or Metastatic RCC
  • Histological confirmation of Renal Cell Carcinoma (RCC)
  • ECOG Performance Status of 0 or 1 and for RCC (Part 2 Arm B), Karnofsky performance status ≥ 70%

You may not qualify if:

  • \- History of allergy or hypersensitivity to study drug components
  • Part 1 Arm A: Advanced HCC
  • History of hepatic encephalopathy or evidence of portal hypertension
  • Active coinfection with hepatitis D virus infection in participants with HBV
  • Part 2 Arm A:Metastatic NSCLC
  • \- Participants with known ALK translocations and EGFR mutation that are sensitive to available targeted inhibitor therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Local Institution - 0020

Hartford, Connecticut, 06106, United States

Location

Local Institution - 0013

Fort Wayne, Indiana, 46804, United States

Location

Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie

Napoli, 80131, Italy

Location

Humanitas-U.O di Oncologia medica ed Ematologia

Rozzano, 20089, Italy

Location

ospedale le scotte-U.O.C. Immunoterapia Oncologica

Siena, 53100, Italy

Location

Local Institution - 0010

Auckland, 1023, New Zealand

Location

Related Links

MeSH Terms

Conditions

NeoplasmsLung NeoplasmsKidney NeoplasmsUrinary Bladder NeoplasmsSkin NeoplasmsLiver Neoplasms

Interventions

IpilimumabNivolumab

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDigestive System NeoplasmsDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 17, 2020

Study Start

June 25, 2020

Primary Completion

January 14, 2021

Study Completion

January 18, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations

US(2)IT(3)NZ(1)