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Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.

Sponsor
InflaRx GmbH (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04812535
Collaborator
(none)
70
Enrollment
25
Locations
2
Arms
37
Anticipated Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, "non comparative", non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms

Condition or Disease Intervention/Treatment Phase
  • Drug: IFX-1
  • Drug: IFX-1 + pembrolizumab combination therapy
 Phase 2

Detailed Description

This is an open-label, non-randomized, Phase II study. Patients will be enrolled in 2 treatment arms (Arm A: IFX-1 monotherapy; Arm B: IFX-1 + pembrolizumab combination therapy), both consisting of 2 stages whereas Arm B starts with a safety run in portion. Enrollment follows an optimal Simon's 2-stage design with an interim analysis of treatment response after Stage 1 prior to patient enrollment into Stage 2.

Arm B will start after ≥3 patients have been treated in Arm A and no toxicity concerns have emerged. In a safety run-in part of Arm B, escalating doses of IFX-1 will be investigated in combination with pembrolizumab in order to identify the MTD or RP2D. Patients will be treated until progression, occurrence of unacceptable toxicity, or treatment discontinuation for any other reason.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Arm A: IFX-1 monotherapy; Arm B: IFX-1 + in combination with approved dosing scheme of pembrolizumabArm A: IFX-1 monotherapy; Arm B: IFX-1 + in combination with approved dosing scheme of pembrolizumab
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open Label, Multicenter Phase II Study of the C5a Antibody IFX-1 Alone or IFX-1 + Pembrolizumab in Patients With PD-1 or PD-L1 Resistant/Refractory Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC)
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: IFX-1 monotherapy

IFX-1 monotherapy

Drug: IFX-1
IFX-1 Monotherapy
Experimental: Arm B: IFX-1 + pembrolizumab combination therapy

IFX-1 + pembrolizumab combination therapy

Drug: IFX-1 + pembrolizumab combination therapy
IFX-1 + pembrolizumab combination therapy

Outcome Measures

Primary Outcome Measures

  1. ORR- Arm A [Up to 36 months]

    Investigator assessed best overall response rate (ORR) for IFX-1, with response being defined as best response of CR/confirmed CR (iCR) or PR/confirmed PR (iPR) per modified RECIST v1.1/iRECIST

  2. DLT- Arm B [Cycle 1 Day - Cycle 1 Day 36]

    Frequency of dose-limiting toxicities (DLTs) by dose cohort

  3. ORR- Arm B [Up to 36 months]

    Investigator assessed best ORR for IFX-1 + pembrolizumab, with response being defined as best response of CR/confirmed CR (iCR) or PR/confirmed PR (iPR) per modified RECIST v1.1/iRECIST

  4. TEAEs- Arm B [Up to 36 months]

    Frequency, severity, and investigational new drug (IND) attribution of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) according to Medical Dictionary for Regulatory Activities (MedDRA) coding (version valid at time of reporting) and the NCI CTCAE grading system (version 5.0, 27 November 2017)

Secondary Outcome Measures

  1. Disease control rate - Arm A [Up to 36 months]

    Disease control rate (CR/iCR+PR/iPR+SD)

  2. Progression-free survival (PFS)- Arm A [Up to 36 months]

    Progression free survival

  3. Overall survival (OS)- Arm A [Up to 36 months]

    Overall survival (OS)

  4. TEAEs- Arm A [Up to 36 months]

    Frequency, severity, and IND attribution of TEAEs and SAEs according to MedDRA coding (version valid at time of reporting) and the NCI CTCAE grading system v5.0

  5. ADAs- Arm A [Up to 27 months]

    Development of human antidrug antibodies (ADAs) against IFX-1

  6. QoL- Arm A [Up to 36 months]

    Changes in QoL as per the European Organisation for Research and Treatment of Cancer (EORTC)-QoL questionnaire (QLQ)-C30 total score

  7. Response (CR/iCR/PR/iPR) and SD- Arm B [Up to 36 months]

    Response (CR/iCR/PR/iPR) and SD duration

  8. Disease control rate- Arm B [Up to 36 months]

    Disease control rate (CR/iCR+PR/iPR+SD)

  9. Progression free survival- Arm B [Up to 36 months]

    Progression free survival-

  10. Overall survival- Arm B [Up to 36 months]

    Overall survival

  11. QoL - Arm B [Up to 36 months]

    Quality of Life

  12. ADAs against IFX-1 - Arm B [Up to 36 months]

    Development of human ADAs against IFX-1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • At least 18 years of age on day of signing informed consent

  • Patients with biopsy-proven, histologically or cytologically confirmed (a.) locally advanced cSCC not amenable for curative treatment or (b.) metastatic cSCC. Patients must have been treated with all approved therapies for (a.) inoperable locally advanced cSCC contraindicated for radiation therapy or (b.) metastatic cSCC

  • Eastern Cooperative Oncology Group performance status (ECOG PS) status of ≤1

  • Patients must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.

  • Patient provides written informed consent for the study.

Exclusion Criteria:

  • Patients with limited cSCC, who do not require systemic therapy

  • Has a diagnosis of immunodeficiency or autoimmune disease, or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 3 weeks prior the first dose of study treatment

  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab or IFX-1 and/or any of their excipients or had a severe (≥Grade 3) infusion-related reaction to treatments with other mAbs

  • Patients who have undergone major surgery <4 weeks prior to starting study treatment

  • Patients with known ≥Grade 3 (per National Cancer Institute common terminology criteria for adverse events [NCI CTCAE] v5.0 criteria) active systemic or cutaneous viral, bacterial, or fungal infection

  • Has known active central nervous system metastases and/or carcinomatous meningitis.

  • Patients with a history of other malignancies during the past 5 years

  • Patients with congestive heart failure, Class III or IV, by New York Heart Association criteria

  • Patients who are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study,

Contacts and Locations

Locations

Site City State Country Postal Code
1 UC San Diego Moores Cancer Center La Jolla California United States 92093
2 Anschutz Cancer Pavilion Aurora Colorado United States 80045
3 Sylvester Comprehensive Cancer Center Miami Florida United States 33136
4 Orlando Health, Inc. Orlando Florida United States 32806
5 H. Lee Moffitt Cancer Center & Research Institute Tampa Florida United States 33612
6 Inova Schar Cancer Institute Fairfax Virginia United States 22031
7 University Hospital Antwerp (UZA) Edegem Belgium 2650
8 St. Augustinus Hospital Wilrijk Belgium 2610
9 University Hospital Center of Grenoble Alpes, Department of Dermatology Grenoble France 38700
10 South Lyon Hospital Center Lyon France 69495
11 CHU APHM la Timone / Aix Marseille University, Dermatology and Skin Cancer Department Marseille France 13385
12 St. Louis Hospital Paris France 75010
13 University Hospital Center of Poitiers, Department of Oncology Poitiers France 86021
14 University Hospital Erlangen, Department of Dermatology Erlangen Germany 91054
15 University Duisburg-Essen, University Hospital Essen, Department of Dermatology Essen Germany 45147
16 Frankfurt University Clinic, Department of Dermatology, Venereology and Allergology Frankfurt Germany 60590
17 University Hospital Hamburg-Eppendorf Hamburg Germany 20246
18 University Hospital Leipzig, Department of Dermatology, Venereology and Allergology Leipzig Germany 04103
19 University Hospital Regensburg, Clinic and Policlinic for Dermatology Regensburg Germany 93053
20 University Hospital Tuebingen, Department of Dermatology Tuebingen Germany 72076
21 University Hospital Vall d'Hebron Barcelona Spain 08035
22 ICO Hospitalet Barcelona Spain 08908
23 MD Anderson International Cancer Center Spain Madrid Spain 28033
24 Regional University Hospital of Malaga Málaga Spain 29010
25 University Clinical Hospital of Salamanca Salamanca Spain 37007

Sponsors and Collaborators

  • InflaRx GmbH

Investigators

  • Principal Investigator: Prof. Dr. D. Schadendorf, MD, University Hospital, Essen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
InflaRx GmbH
ClinicalTrials.gov Identifier:
NCT04812535
Other Study ID Numbers:
  • IFX-1 P2.8
  • KEYNOTE MK3475-PNA93
First Posted:
Mar 23, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by InflaRx GmbH
SCC
metastatic
locally advanced
Additional relevant MeSH terms:
Pembrolizumab
Vilobelimab

Study Results

No Results Posted as of Jun 30, 2022