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

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ClinicalTrials.gov Identifier: NCT04812535
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
InflaRx GmbH

Study Description
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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
SSC 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : June 1, 2021
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. ORR- Arm A [ Time Frame: 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 [ Time Frame: Cycle 1 Day - Cycle 1 Day 36 ]
    Frequency of dose-limiting toxicities (DLTs) by dose cohort

  3. ORR- Arm B [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 36 months ]
    Disease control rate (CR/iCR+PR/iPR+SD)

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

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

  4. TEAEs- Arm A [ Time Frame: 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 [ Time Frame: Up to 27 months ]
    Development of human antidrug antibodies (ADAs) against IFX-1

  6. QoL- Arm A [ Time Frame: 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 [ Time Frame: Up to 36 months ]
    Response (CR/iCR/PR/iPR) and SD duration

  8. Disease control rate- Arm B [ Time Frame: Up to 36 months ]
    Disease control rate (CR/iCR+PR/iPR+SD)

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

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

  11. QoL - Arm B [ Time Frame: Up to 36 months ]
    Quality of Life

  12. ADAs against IFX-1 - Arm B [ Time Frame: Up to 36 months ]
    Development of human ADAs against IFX-1


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04812535


Contacts
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Contact: Claus Thielert, PhD +493641508180 info@inflarx.de
Contact: Mirna Castro, PhD +493641508180 info@inflarx.de

Locations
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Sponsors and Collaborators
InflaRx GmbH
Investigators
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Principal Investigator: Prof. Dr. D. Schadendorf, MD University Hospital, Essen
More Information
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Responsible Party: InflaRx GmbH
ClinicalTrials.gov Identifier: NCT04812535    
Other Study ID Numbers: IFX-1 P2.8
KEYNOTE MK3475-PNA93 ( Other Identifier: Merck & Co, Inc )
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: June 2022

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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:
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Pembrolizumab
Vilobelimab
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs