ClinicalTrials.gg
Status unknownNCT04397770Updated May 21, 2020

Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma

A Phase 2 interventional study of SHR1210 and apatinib mesylate in Melanoma, sponsored by Peking University Cancer Hospital & Institute. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-21.

Sponsored by Peking University Cancer Hospital & Institute · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

It is a single-center,exploratory clinical trial aimed to evaluate the objective response rate (ORR) of Camrelizumab combined with apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma.

02

Conditions studied

  • Melanoma

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03

In context

Melanoma

3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.

This study's planned enrollment of 40 is close to the median of 38 across 2,400 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 266 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. age:18-75 years, male or female.
  2. Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
  3. Has not received any systematic anti-tumor drug treatment.
  4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  5. ECOG 0-1.
  6. Adequate organ function.
  7. Life expectancy of greater than 12 weeks.
  8. Patient has given written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
  2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
  3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
  4. Subjects with any active autoimmune disease or history of autoimmune disease
  5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
  6. Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
  7. Received a live vaccine within 4 weeks of the first dose of study medication.
  8. Pregnancy or breast feeding.
  9. Decision of unsuitableness by principal investigator or physician-in charge.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Camre+Apa+TMZ

    Drug: SHR1210 · Drug: apatinib mesylate · Drug: Temozolomide Injection

Interventions

  • SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

  • apatinib Mesylate is a small molecule tyrosine kinase inhibitor,Through selectively inhibiting the tyrosine kinase activity of the vascular endothelial growth factor receptor 2 (VEGFR-2).

  • Temozolomide is an imidazole tetrazine derivative of the alkylating agent dacarbazine.Temozolomide is not directly active but undergoes rapid, spontaneous, non-enzymatic conversion at physiologic pH to the cytotoxic compound, monomethyl triazeno imidazole carboxamide (MTIC).

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What researchers measure

Primary outcomes

  1. ORR

    Objective Response Rate

    Time frame: Through study uncompletion, an average of 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Mao L, Lian B, Li C, Bai X, Zhou L, Cui C, Chi Z, Sheng X, Wang X, Tang B, Yan X, Li S, Kong Y, Dai J, Wei X, Li J, Duan R, Xu H, Wu X, Yang Y, Cheng F, Zhang C, Xia F, Pang Z, Guo J, Si L. Camrelizumab Plus Apatinib and Temozolomide as First-Line Treatment in Patients With Advanced Acral Melanoma: The CAP 03 Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2023 Aug 1;9(8):1099-1107. doi: 10.1001/jamaoncol.2023.1363. PubMed 37261804 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04397770
Responsible party
Jun Guo (Associate Director of Peking University Cancer Hospital, Peking University Cancer Hospital & Institute) — Principal investigator
First posted
May 21, 2020
Start date
May 2020 (estimated)
Primary completion
Jun 2022 (estimated)
Completion
Feb 2023 (estimated)
Last update
May 21, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Apatinib · Temozolomide

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